Trial Outcomes & Findings for Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty (NCT NCT01112735)

Last Updated: 2018-07-06

Results Overview

Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30 cc.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Day 0 (Surgery Day) to Day 90

Results posted on

2018-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	ARTISS ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care Standard of care
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARTISS n=20 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=20 Participants Standard of care	Total n=40 Participants Total of all reporting groups
Age, Continuous	40.90 Years STANDARD_DEVIATION 7.89 • n=5 Participants	45.60 Years STANDARD_DEVIATION 10.32 • n=7 Participants	43.25 Years STANDARD_DEVIATION 9.38 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (Surgery Day) to Day 90

Population: Full Analysis Set (FAS) consists of all subjects who were randomized (ie, the investigator opened the randomization envelope) and treated and who had an available assessment for the primary efficacy endpoint.

Outcome measures

Outcome measures
Measure	ARTISS n=20 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=20 Participants Standard of care
Total Drainage Volume Collected Until Drain Removal	407.45 mL Standard Deviation 470.36	595.90 mL Standard Deviation 519.46

SECONDARY outcome

Timeframe: Day 0 (Surgery Day) to Day 90

Population: FAS

The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.

Outcome measures

Outcome measures
Measure	ARTISS n=20 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=20 Participants Standard of care
Occurrence of Seroma	8 Events	5 Events

SECONDARY outcome

Timeframe: Day 0 (Surgery Day) to Day 90

Population: FAS

Outcome measures

Outcome measures
Measure	ARTISS n=20 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=20 Participants Standard of care
Occurrence of Hematoma	0 Events	0 Events

SECONDARY outcome

Timeframe: Day 0 (Surgery Day) up to Day 90

Population: FAS

The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30cc.

Outcome measures

Outcome measures
Measure	ARTISS n=20 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=20 Participants Standard of care
Time to Drain Removal	6.8 Days Standard Deviation 7.11	9.55 Days Standard Deviation 5.82

SECONDARY outcome

Timeframe: Day 0 (Surgery Day) to Day 90

Population: FAS

Number of interventions recorded.

Outcome measures

Outcome measures
Measure	ARTISS n=8 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=5 Participants Standard of care
Number of Fluid Aspiration for Seromas	5 Interventions Standard Deviation 4.34	3.2 Interventions Standard Deviation 1.64

SECONDARY outcome

Timeframe: Day 0 (Surgery Day) to Day 90

Population: FAS

Volume of fluid recovered was recorded.

Outcome measures

Outcome measures
Measure	ARTISS n=8 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=5 Participants Standard of care
Total Volume of Fluid Aspirations for Seromas	226.13 mL Standard Deviation 157.78	152.2 mL Standard Deviation 150.34

SECONDARY outcome

Timeframe: Days 0 (Baseline), 3, 7, 14, 28, 60, 90

Population: FAS

Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand \& Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO: ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO.

Outcome measures

Outcome measures
Measure	ARTISS n=20 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=20 Participants Standard of care
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus Day 3	0.92 Units on a Scale Standard Deviation 1.79	0.89 Units on a Scale Standard Deviation 1.69
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus Day 7	0.55 Units on a Scale Standard Deviation 1.37	0.73 Units on a Scale Standard Deviation 1.34
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus Day 14	0.78 Units on a Scale Standard Deviation 1.42	0.54 Units on a Scale Standard Deviation 1.08
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus Day 28	0.63 Units on a Scale Standard Deviation 1.41	0.53 Units on a Scale Standard Deviation 1.28
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus Day 60	0.5 Units on a Scale Standard Deviation 1.26	0.3 Units on a Scale Standard Deviation 1.46
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus Day 90	0.38 Units on a Scale Standard Deviation 0.95	0.19 Units on a Scale Standard Deviation 1.17

SECONDARY outcome

Timeframe: Days 0 (Baseline), 3, 7, 14, 28, 60, 90

Population: FAS

Outcome measures

Outcome measures
Measure	ARTISS n=20 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=20 Participants Standard of care
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus Day 3	1.81 Score on a Scale Standard Deviation 1.83	1.78 Score on a Scale Standard Deviation 1.67
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus Day 7	1.47 Score on a Scale Standard Deviation 1.32	1.02 Score on a Scale Standard Deviation 1.52
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus Day 14	1.28 Score on a Scale Standard Deviation 1.47	0.49 Score on a Scale Standard Deviation 1.25
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus Day 28	1.21 Score on a Scale Standard Deviation 1.43	0.81 Score on a Scale Standard Deviation 1.45
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus Day 60	0.97 Score on a Scale Standard Deviation 1.67	0.50 Score on a Scale Standard Deviation 1.55
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus Day 90	1.00 Score on a Scale Standard Deviation 1.68	0.84 Score on a Scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: Day 3, 7, 14, 28, 60, 90

Population: FAS

Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 \[no pain\] to 10 \[worst possible pain\]) the patient experienced at the site of surgery at the time of the visit.

Outcome measures

Outcome measures
Measure	ARTISS n=20 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=20 Participants Standard of care
Summary of Pain Assessment by Visit Day 3	3.68 Score on a Scale Standard Deviation 2.40	4 Score on a Scale Standard Deviation 2.03
Summary of Pain Assessment by Visit Day 7	2.7 Score on a Scale Standard Deviation 2.11	2.8 Score on a Scale Standard Deviation 1.79
Summary of Pain Assessment by Visit Day 14	1.7 Score on a Scale Standard Deviation 1.53	1.7 Score on a Scale Standard Deviation 1.34
Summary of Pain Assessment by Visit Day 28	1.05 Score on a Scale Standard Deviation 1.73	0.37 Score on a Scale Standard Deviation 0.50
Summary of Pain Assessment by Visit Day 60	0.37 Score on a Scale Standard Deviation 0.76	0.3 Score on a Scale Standard Deviation 0.57
Summary of Pain Assessment by Visit Day 90	0.3 Score on a Scale Standard Deviation 0.92	0.15 Score on a Scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: Day 3, 7, 14, 28, 60, 90

Population: FAS

Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 \[no numbness\] to 10 \[complete numbness\]) that the patient experienced at the time of the visit.

Outcome measures

Outcome measures
Measure	ARTISS n=20 Participants ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.	Standard of Care n=20 Participants Standard of care
Summary of Numbness Assessment by Visit Day 3	5.16 Score on a Scale Standard Deviation 3.24	6.30 Score on a Scale Standard Deviation 2.39
Summary of Numbness Assessment by Visit Day 7	5.50 Score on a Scale Standard Deviation 2.54	4.95 Score on a Scale Standard Deviation 2.21
Summary of Numbness Assessment by Visit Day 14	4.45 Score on a Scale Standard Deviation 2.52	4.35 Score on a Scale Standard Deviation 2.32
Summary of Numbness Assessment by Visit Day 28	3.25 Score on a Scale Standard Deviation 1.92	3.42 Score on a Scale Standard Deviation 2.61
Summary of Numbness Assessment by Visit Day 60	3.37 Score on a Scale Standard Deviation 1.74	3.16 Score on a Scale Standard Deviation 2.29
Summary of Numbness Assessment by Visit Day 90	2.85 Score on a Scale Standard Deviation 1.69	2.11 Score on a Scale Standard Deviation 1.91

Adverse Events

ARTISS

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ARTISS n=20 participants at risk ARTISS will be used as an adjuvant to standard of care. FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma): Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.	Standard of Care n=20 participants at risk Standard of care Standard of care: Standard of care
Vascular disorders Hypertension	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.

Other adverse events

Additional Information

Clinical Trials Disclosure Group

Baxter Healthcare Corporation

Phone: 734-646-8214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	ARTISS n=20 participants at risk ARTISS will be used as an adjuvant to standard of care. FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma): Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.	Standard of Care n=20 participants at risk Standard of care Standard of care: Standard of care
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Gastrointestinal disorders Nausea	15.0% 3/20 • Number of events 3 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Infections and infestations Incision Site Infection	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Infections and infestations Abdominal Abscess	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Infections and infestations Cellulitis	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Infections and infestations Urinary Tract Infection	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Injury, poisoning and procedural complications Seroma	40.0% 8/20 • Number of events 9 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	25.0% 5/20 • Number of events 6 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Injury, poisoning and procedural complications Wound Dehiscence	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Investigations Staphylococcus Test Positive	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Psychiatric disorders Depression	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Respiratory, thoracic and mediastinal disorders Atelectasis	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Skin and subcutaneous tissue disorders Pruritus Generalized	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Injury, poisoning and procedural complications Incision Site Complication	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Nervous system disorders Lethargy	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	5.0% 1/20 • Number of events 1 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Skin and subcutaneous tissue disorders Skin Necrosis	0.00% 0/20 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.	10.0% 2/20 • Number of events 2 • 90 days An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.