NCT03269994

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 967 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Pancreas Cancer
• Pancreatic Diseases

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2017-11-21
• Primary completion: 2025-01-28
• Completion: 2025-01-28
• First posted: 2017-09-01
• Last updated: 2025-10-21
• Results posted: 2025-10-21

Locations

32 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study