Title
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
Phase
Phase 3Lead Sponsor
Memorial Sloan-Kettering Cancer CenterStudy Type
InterventionalStatus
Active, not recruitingIndication/Condition
Pancreatic Cancer Pancreas Cancer Pancreatic DiseasesIntervention/Treatment
Cefoxitin Piperacillin-tazobactam [tazobactam (110242), piperacillin (58782)]Study Participants
962The 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.
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.
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.
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
