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

Investigating Investigational Antibiotics for Preventing Infections After Surgery

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

This study aims to leverage the ACS NSQIP data collection processes and infrastructure in collaboration with the AHPBA to prospectively compare two FDA approved antibiotics used as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy (PD). Specifically, this is a pragmatic, multi-center randomized controlled trial comparing the SCIP-recommended antimicrobial prophylaxis of a second generation cephalosporin, cefoxitin (which is FDA approved for use as a surgical antibiotic prophylaxis), with piperacillin-tazobactam (which is not FDA approved for surgical antibiotic prophylaxis, but is often used in this way off label) in patients undergoing elective PD.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Disease,Pancreatic Cancer
  • Age: 18 years - 100 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 1709446757 (SURG-MSK-HOUSE-ANTIBIOTIC)

This study investigates the effectiveness of two antibiotics, cefoxitin and piperacillin-tazobactam, in preventing infections at the site of surgery after a procedure called pancreatoduodenectomy. A pancreatoduodenectomy is a surgery to remove part of the pancreas and nearby organs. The study uses data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) to ensure accurate comparisons.

Participants in the study will be randomly assigned to receive either cefoxitin or piperacillin-tazobactam before their surgery. Cefoxitin is approved by the FDA for preventing infections during surgery, while piperacillin-tazobactam is commonly used for this purpose but is not specifically approved for it.

  • Who can participate: Participants should be adults who are scheduled to undergo a pancreatoduodenectomy and meet other health criteria as determined by the study.
  • Study details: Participants will receive one of the investigational antibiotics before their surgery. One is an approved antibiotic for surgery, while the other is used off-label for this purpose. A placebo will not be used in this study.

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