Phase 3
Completed N=967
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
Source: ClinicalTrials.gov NCT03269994 ↗Enrolled (actual)
967
Serious AEs
1.9%
Results posted
Oct 2025
Primary outcomePrimary: Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. — 400; 378 Participants
◆ Published Evidence
Highly cited
124citations · ~41 / year
Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial.
Summary
The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.
Linked Publications (2)
-
Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial.
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Cefoxitin versus piperacillin-tazobactam as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy: protocol for a randomised controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. |
400; 378 | — |
Eligibility Criteria
Inclusion Criteria
- Age >/= 18 years
- Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Exclusion Criteria
- Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD
- Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors
- Patients who are otherwise ineligible to receive the antibiotics in this study
- Patients highly unlikely to undergo PD according to the surgeon's judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc.
- Patients with long-term glucocorticosteroid use. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
- Patients unable to provide informed consent
- Creatinine clearance (CrCl) </= 40 mL/min
- Patients receiving hemodialysis or peritoneal dialysis
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
Data sourced from ClinicalTrials.gov (NCT03269994) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.