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

• Status: Recruiting
• Trial end date: 2022-08-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• 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; Providence Health & Services; Rhode Island Hospital; Stony Brook Medicine; Sunnybrook Health Sciences Centre, Canada; Temple University; The Cleveland Clinic; The Ohio State University Wexner Medical Center; 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
• Treatments: Cefotaxime; Cefoxitin; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

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)
• 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