A Phase III Multicenter Open Label Randomized Controlled Trial of Cefoxitin versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
Michael House, MD
Primary Investigator
Overview
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.
Description
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
You may be eligible for this study if you meet the following criteria:
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Conditions:
Pancreatic Cancer, Pancreatic Disease
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Age: Between 18 Years - 100 Years
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Gender: All