Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences Center (Juravinski Hospital), Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefoxitin

Drug

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

Drug

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.

Primary outcomes

Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.

Time frame: 30 days

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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

Advocate Illinois Masonic Medical Center
Albany Medical College
Baptist Memorial Health Care Corporation
Baylor Scott and White Health
Brody School of Medicine at East Carolina University
Emory University
Fox Chase Cancer Center
Gundersen Lutheran Medical Center
Hackensack Meridian Health
Hamilton Health Sciences Center
Indiana University
Intermountain Health Care, Inc.
Jersey Shore Medical Center (Hackensack Meridian)
Johns Hopkins University
Massachusetts General Hospital
Milton S. Hershey Medical Center
Montefiore Medical Center/Albert Einstein College of Medicine
Mount Sinai Hospital, New York
North Shore University HealthSystem
Northwestern University
Ohio State University
Providence Health & Services
Rhode Island Hospital
Stony Brook Medicine
Sunnybrook Health Sciences Centre
Temple University
The Cleveland Clinic
The Ottowa Hospital/University of Ottowa
Thomas Jefferson University
University of California, Davis
University of Chicago
University of Iowa
University of Texas Southwestern Medical Center
University of Utah
University of Wisconsin, Madison
Universtiy of Mississippi Medical Center
Washington University School of Medicine

Registry information

Official study title

A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy

Important dates

Study start: 2017
Primary completion: 2025
Study completion: 2025
First posted: Sep 1, 2017
Registry last updated: Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed