Trial Outcomes & Findings for Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery (NCT NCT01888367)

NCT ID: NCT01888367

Last Updated: 2016-10-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 445 participants
• Primary outcome timeframe: Within 30 days of surgery
• Results posted on: 2016-10-11

Participant Flow

Participant milestones

Measure	DFA-02 Antibiotic Gel Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	DFA-02 Placebo Gel Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Standard of Care Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Overall Study STARTED	296	71	78
Overall Study COMPLETED	288	66	73
Overall Study NOT COMPLETED	8	5	5

Reasons for withdrawal

Measure	DFA-02 Antibiotic Gel Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	DFA-02 Placebo Gel Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Standard of Care Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Overall Study Physician Decision	3	4	2
Overall Study Death	2	0	1
Overall Study Withdrawal by Subject	1	0	1
Overall Study Lost to Follow-up	1	1	0
Overall Study Protocol Violation	0	0	1
Overall Study 30-Day Visit Too Early (< 28 Days)	1	0	0

Baseline Characteristics

Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery

Baseline characteristics by cohort

Measure	DFA-02 Antibiotic Gel n=296 Participants Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	DFA-02 Placebo Gel n=71 Participants Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Standard of Care n=78 Participants Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.	Total n=445 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 14.6 • n=5 Participants	58.8 years STANDARD_DEVIATION 15.7 • n=7 Participants	59.6 years STANDARD_DEVIATION 14.7 • n=5 Participants	59.8 years STANDARD_DEVIATION 14.8 • n=4 Participants
Sex: Female, Male Female	142 Participants n=5 Participants	33 Participants n=7 Participants	45 Participants n=5 Participants	220 Participants n=4 Participants
Sex: Female, Male Male	154 Participants n=5 Participants	38 Participants n=7 Participants	33 Participants n=5 Participants	225 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	45 Participants n=4 Participants
Race (NIH/OMB) White	255 Participants n=5 Participants	60 Participants n=7 Participants	74 Participants n=5 Participants	389 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	296 participants n=5 Participants	71 participants n=7 Participants	78 participants n=5 Participants	445 participants n=4 Participants

PRIMARY outcome

Timeframe: Within 30 days of surgery

Population: The number of SSIs from the day of surgery to 30 days post-op could only be assessed in the 427 completed patients. Central adjudication by the Clinical Events Committee was not able to assess the presence or absence of SSI for two patients, one in the DFA-02 group and one in the SOC group so the total analyzed is only 425.

Outcome measures

Measure	DFA-02 Antibiotic Gel n=287 Participants Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	DFA-02 Placebo Gel n=66 Participants Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Standard of Care n=72 Participants Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Number of Patients With Surgical Site Infections	42 participants	14 participants	25 participants

SECONDARY outcome

Timeframe: Within 30 days of surgery

Population: The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the patients who did not receive gel were counted in the SOC group.

Outcome measures

Measure	DFA-02 Antibiotic Gel n=284 Participants Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	DFA-02 Placebo Gel n=64 Participants Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Standard of Care n=93 Participants Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Number of Patients With Adverse Events	267 participants	61 participants	86 participants

SECONDARY outcome

Timeframe: Within 4 days of surgery

Population: 402 of the 445 patients had both baseline and post-operative creatinine measurements. Safety analyses were "as treated" so patients randomized to gel but did not receive it in surgery were counted in the SOC group.

Change from baseline in micromoles/liter

Outcome measures

Measure	DFA-02 Antibiotic Gel n=262 Participants Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	DFA-02 Placebo Gel n=61 Participants Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Standard of Care n=79 Participants Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Change in Serum Creatinine Measurements From Baseline	-10.2 micromoles/liter Standard Deviation 18.2	-9.9 micromoles/liter Standard Deviation 12.8	-10.2 micromoles/liter Standard Deviation 27.0

SECONDARY outcome

Timeframe: Through post-operative Day 4

Population: Safety analyses were "as treated" so patients who were randomized to gel but did not receive it are counted as SOC. For 4 patients, the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized.

Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.

Outcome measures

Measure	DFA-02 Antibiotic Gel n=284 Participants Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	DFA-02 Placebo Gel n=64 Participants Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Standard of Care n=93 Participants Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Cumulative ASEPSIS Score for Each Patient	17.5 units on a scale Standard Deviation 8.1	18.5 units on a scale Standard Deviation 3.5	23.0 units on a scale Standard Deviation 3.5

Adverse Events

DFA-02 Antibiotic Gel

Serious events: 59 serious events

Other events: 267 other events

Deaths: 0 deaths

DFA-02 Placebo Gel

Serious events: 14 serious events

Other events: 61 other events

Deaths: 0 deaths

Standard of Care

Serious events: 21 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Measure	DFA-02 Antibiotic Gel n=284 participants at risk Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	DFA-02 Placebo Gel n=64 participants at risk Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Standard of Care n=93 participants at risk Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Infections and infestations Pelvic Abscess	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.2% 4/64 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Pneuomia	1.1% 3/284 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Abdominal Abscess	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	3.2% 3/93 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Abscess	0.70% 2/284 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Peritonitis	0.70% 2/284 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Wound Infection	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Abdominal Infection	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Abdominal Sepsis	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Clostridium difficile Infection	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Nausea	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Hematoma Infection	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Incision Site Infection	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Postoperative Wound Infection	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Sepsis	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Septic Shock	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Splenic Abscess	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Subdiaphragmatic Abscess	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Urinary Tract Infection	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Small Intestine Obstruction	1.4% 4/284 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Enterocutaneous Fistula	1.1% 3/284 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Ileus	0.70% 2/284 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Gastrointestinal Hemorrhage	0.70% 2/284 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Abdominal Wall Hematoma	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Abdominal Pain	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Intra-abdominal Hemorrhage	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Localized Abdominal Fluid Collection	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Rectal Hemorrhage	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Small Intestinal Perforation	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Postoperative Ileus	2.5% 7/284 • Number of events 7 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	3.1% 2/64 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	4.3% 4/93 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Anastomotic Leak	0.70% 2/284 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Abdominal Wound Dehiscence	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Anastomotic Complication	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Bladder Injury	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Hip Fracture	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Postoperative Renal Failure	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Procedural Vomiting	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Splenic Rupture	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Wound Secretion	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	1.1% 3/284 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.1% 3/284 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.1% 3/284 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Dehydration	2.1% 6/284 • Number of events 6 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Failure to Thrive	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Cardiac disorders Atrial Fibrillation	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Cardiac disorders Cardiac Arrest	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Cardiac disorders Myocardial Infarction	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Cardiac disorders Ventricular Tachycardia	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Blood and lymphatic system disorders Anemia	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
General disorders Asthenia	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
General disorders Device Dislocation	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
General disorders Systemic Inflammatory Response Syndrome	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Renal and urinary disorders Acute Kidney Injury	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	2.2% 2/93 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer Metastatic	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.00% 0/284 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Psychiatric disorders Mental Status Changes	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Reproductive system and breast disorders Pelvic Pain	0.35% 1/284 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.

Other adverse events

Measure	DFA-02 Antibiotic Gel n=284 participants at risk Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	DFA-02 Placebo Gel n=64 participants at risk Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Standard of Care n=93 participants at risk Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Injury, poisoning and procedural complications Procedural Nausea	9.9% 28/284 • Number of events 28 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	12.5% 8/64 • Number of events 8 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	10.8% 10/93 • Number of events 10 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Procedural Pain	50.4% 143/284 • Number of events 143 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	50.0% 32/64 • Number of events 32 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	55.9% 52/93 • Number of events 52 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Anemia Postoperative	9.2% 26/284 • Number of events 26 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	9.4% 6/64 • Number of events 6 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	12.9% 12/93 • Number of events 12 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Incision Site Pain	6.0% 17/284 • Number of events 17 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	4.7% 3/64 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	3.2% 3/93 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Postoperative Ileus	4.2% 12/284 • Number of events 12 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	4.7% 3/64 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	4.3% 4/93 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Injury, poisoning and procedural complications Seroma	4.2% 12/284 • Number of events 12 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	7.8% 5/64 • Number of events 5 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Nausea	41.5% 118/284 • Number of events 118 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	50.0% 32/64 • Number of events 32 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	44.1% 41/93 • Number of events 41 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Vomiting	13.7% 39/284 • Number of events 39 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	23.4% 15/64 • Number of events 15 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	11.8% 11/93 • Number of events 11 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Diarrhea	8.8% 25/284 • Number of events 25 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	3.2% 3/93 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Dyspepsia	6.0% 17/284 • Number of events 17 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.2% 4/64 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	2.2% 2/93 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Constipation	4.9% 14/284 • Number of events 14 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.2% 4/64 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.1% 1/93 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Gastrointestinal disorders Abdominal Distention	3.5% 10/284 • Number of events 10 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	4.7% 3/64 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	5.4% 5/93 • Number of events 5 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Hyperglycemia	16.2% 46/284 • Number of events 46 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	12.5% 8/64 • Number of events 8 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	19.4% 18/93 • Number of events 18 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Hypokalemia	15.1% 43/284 • Number of events 43 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	10.9% 7/64 • Number of events 7 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	18.3% 17/93 • Number of events 17 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Hypophosphatemia	13.7% 39/284 • Number of events 39 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	14.1% 9/64 • Number of events 9 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	15.1% 14/93 • Number of events 14 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Hypocalcemia	13.0% 37/284 • Number of events 37 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	10.9% 7/64 • Number of events 7 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	16.1% 15/93 • Number of events 15 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Hypomagnesemia	8.8% 25/284 • Number of events 25 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	7.8% 5/64 • Number of events 5 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	12.9% 12/93 • Number of events 12 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Hypoproteinemia	9.2% 26/284 • Number of events 26 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.2% 4/64 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	10.8% 10/93 • Number of events 10 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Hypoalbuminemia	9.9% 28/284 • Number of events 28 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	3.1% 2/64 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	8.6% 8/93 • Number of events 8 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Hyponatremia	6.7% 19/284 • Number of events 19 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.2% 4/64 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	8.6% 8/93 • Number of events 8 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Metabolism and nutrition disorders Hypochloremia	4.9% 14/284 • Number of events 14 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	1.6% 1/64 • Number of events 1 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	5.4% 5/93 • Number of events 5 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Investigations Urine Output Decreased	9.2% 26/284 • Number of events 26 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	7.8% 5/64 • Number of events 5 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	10.8% 10/93 • Number of events 10 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Investigations Oxygen Saturation Decreased	5.6% 16/284 • Number of events 16 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	4.7% 3/64 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.5% 6/93 • Number of events 6 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Investigations Amylase Decreased	1.1% 3/284 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/64 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	5.4% 5/93 • Number of events 5 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	9.9% 28/284 • Number of events 28 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	10.9% 7/64 • Number of events 7 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	3.2% 3/93 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Incision Site Infection	6.0% 17/284 • Number of events 17 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	4.7% 3/64 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	4.3% 4/93 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Infections and infestations Pelvic Abscess	0.70% 2/284 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.2% 4/64 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	0.00% 0/93 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
General disorders Pyrexia	10.6% 30/284 • Number of events 30 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	9.4% 6/64 • Number of events 6 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	7.5% 7/93 • Number of events 7 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Skin and subcutaneous tissue disorders Pruritus	14.8% 42/284 • Number of events 42 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	14.1% 9/64 • Number of events 9 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	16.1% 15/93 • Number of events 15 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Cardiac disorders Tachycardia	16.2% 46/284 • Number of events 46 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	21.9% 14/64 • Number of events 14 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	16.1% 15/93 • Number of events 15 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Blood and lymphatic system disorders Leukocytosis	10.2% 29/284 • Number of events 29 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	9.4% 6/64 • Number of events 6 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	12.9% 12/93 • Number of events 12 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Blood and lymphatic system disorders Anemia	8.5% 24/284 • Number of events 24 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.2% 4/64 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	10.8% 10/93 • Number of events 10 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Renal and urinary disorders Hematuria	4.2% 12/284 • Number of events 12 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	12.5% 8/64 • Number of events 8 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	8.6% 8/93 • Number of events 8 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Renal and urinary disorders Urinary Retention	4.9% 14/284 • Number of events 14 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.2% 4/64 • Number of events 4 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	9.7% 9/93 • Number of events 9 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Vascular disorders Hypertension	12.0% 34/284 • Number of events 34 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	10.9% 7/64 • Number of events 7 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	6.5% 6/93 • Number of events 6 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Vascular disorders Hypotension	8.1% 23/284 • Number of events 23 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	3.1% 2/64 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	9.7% 9/93 • Number of events 9 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Psychiatric disorders Anxiety	6.7% 19/284 • Number of events 19 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	3.1% 2/64 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	7.5% 7/93 • Number of events 7 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Psychiatric disorders Insomnia	5.3% 15/284 • Number of events 15 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	3.1% 2/64 • Number of events 2 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	9.7% 9/93 • Number of events 9 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Nervous system disorders Headache	6.0% 17/284 • Number of events 17 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	4.7% 3/64 • Number of events 3 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.	5.4% 5/93 • Number of events 5 • From time of surgery until 30 days post-op. Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.

Additional Information

VP, Drug Development

Promius Pharma, LLC, Dr. Reddy's Laboratories

Phone: 609-375-9855

Email: kallenby@drreddys.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60