A Phase III Multicenter Open Label Randomized Controlled Trial of Cefoxitin versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
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- STATUS
- Recruiting
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.
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.
Details
| Condition | Pancreatic Disease,Pancreatic Cancer |
|---|---|
| Age | 18years - 100years |
| Clinical Study Identifier | TX8823 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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