Trial Outcomes & Findings for Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy? (NCT NCT03269994)
NCT ID: NCT03269994
Last Updated: 2025-10-21
Results Overview
To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
967 participants
Primary outcome timeframe
30 days
Results posted on
2025-10-21
Participant Flow
Participant milestones
| Measure |
Cefoxitin
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
Piperacillin-tazobactam
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
|---|---|---|
|
Overall Study
STARTED
|
484
|
483
|
|
Overall Study
COMPLETED
|
400
|
378
|
|
Overall Study
NOT COMPLETED
|
84
|
105
|
Reasons for withdrawal
| Measure |
Cefoxitin
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
Piperacillin-tazobactam
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Unresectable at surgery
|
39
|
58
|
|
Overall Study
Patient canceled surgery
|
5
|
14
|
|
Overall Study
Preoperative progression
|
14
|
9
|
|
Overall Study
Preoperative infection
|
10
|
4
|
|
Overall Study
Kidney insufficiency
|
1
|
0
|
|
Overall Study
Drug allergy
|
0
|
2
|
|
Overall Study
Operation changed to different resection
|
0
|
10
|
|
Overall Study
Preoperative steroid
|
0
|
3
|
|
Overall Study
Accrual Closed
|
2
|
0
|
Baseline Characteristics
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
Baseline characteristics by cohort
| Measure |
Cefoxitin
n=400 Participants
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
Piperacillin-tazobactam
n=378 Participants
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
Total
n=778 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.0 years
n=5 Participants
|
66.8 years
n=7 Participants
|
67.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
177 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
223 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
456 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
307 Participants
n=5 Participants
|
280 Participants
n=7 Participants
|
587 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
87 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 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
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
276 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
534 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
|
93 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
400 Participants
n=5 Participants
|
378 Participants
n=7 Participants
|
778 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysTo compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
Outcome measures
| Measure |
Cefoxitin
n=400 Participants
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
Piperacillin-tazobactam
n=378 Participants
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
|---|---|---|
|
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.
|
400 Participants
|
378 Participants
|
Adverse Events
Cefoxitin
Serious events: 10 serious events
Other events: 0 other events
Deaths: 10 deaths
Piperacillin-tazobactam
Serious events: 5 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cefoxitin
n=400 participants at risk
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
Piperacillin-tazobactam
n=378 participants at risk
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
|
|---|---|---|
|
General disorders
Death
|
2.5%
10/400 • 30 days
|
1.3%
5/378 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael D'Angelica, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3226
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place