Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery

Phase 3 Unknown 2000 enrolled Poitiers University Hospital

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The goal of this prospective, multicentre, double-blind, randomized clinical trial is to compare intermittent cefoxitin administration to loading bolus followed by continuous infusion for surgical antibiotic prophylaxis in colorectal surgery. The main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing SSI within 30 days after colorectal surgery

Timeline

Start: 2023-06-22
Primary completion: 2025-05
Completion: 2025-06

Publications

Saint-Genis Q, Birckener J, Gourdou V, Nicolle C, Garnier M, Schwindenhammer V, Hannezo C, Aveline C, Cinotti R, Puisney B, Garot M, Chevalier S, Aubert JS, Wodey M, Lasocki S, Lecoeur S, Lagarrigue CJ, Li A, Faucher M, Foucher Y, Frasca D, Boisson M. Multicentre, double-blind, randomised controlled clinical trial comparing intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: the PROPHYLOXITIN study protocol. BMJ Open. 2025 Jan 28;15(1):e088306. doi: 10.1136/bmjopen-2024-088306.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cefoxitin	Small molecule	0.5 g	—
Subject	Cefoxitin	Small molecule	1 g	—
Subject	Cefoxitin	Small molecule	2 g	—

Indications

No indication recorded.