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. 2025 Jan 28;15(1):e088306.
doi: 10.1136/bmjopen-2024-088306.

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

Quentin Saint-Genis  1 , Julien Birckener  2 , Vincent Gourdou  3 , Claire Nicolle  4 , Marc Garnier  5 , Victor Schwindenhammer  6 , Cécile Hannezo  7 , Christophe Aveline  8 , Raphaël Cinotti  9 , Benjamin Puisney  10 , Matthias Garot  11 , Stéphanie Chevalier  12 , Jean-Sébastien Aubert  13 , Maxime Wodey  14 , Sigismond Lasocki  15 , Sylvain Lecoeur  16 , Charles Jean Lagarrigue  17 , Anne Li  18 , Marion Faucher  19 , Yohann Foucher  20 , Denis Frasca  21 , Matthieu Boisson  22
Affiliations

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

Quentin Saint-Genis et al. BMJ Open. .

Abstract

Introduction: Surgical site infections (SSIs) are the second leading cause of healthcare-associated infections in Europe with the highest rates being reported in colorectal surgery (ranging from 9% to 30%). Surgical antibiotic prophylaxis (SAP) is one of the most efficient measures for SSI prevention and should be started before surgical incision. Cefoxitin is an antibiotic widely used as SAP for colorectal surgery, but its continuous administration is currently the subject of debate due to its potential pharmacokinetic advantages. Therefore, the aim of the PROPHYLOXITIN study is to demonstrate that a loading dose followed by continuous infusion of cefoxitin during colorectal surgery (intervention group) decreases the rate of SSI compared to an intermittent bolus administration (control group).

Methods and analysis: The PROPHYLOXITIN study is a superiority, prospective, double-blind, randomised and multicentre study of 2000 patients undergoing colorectal surgery. The primary objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over intermittent bolus administration in reducing the proportion of SSIs within 30 days after colorectal surgery. Subjects will be randomised 1:1 using a secure web-based random-number generator to one of two study groups. Randomised allocation of treatment will be done by minimisation and stratified according to the centre, the localisation of surgery (colon or rectum) and the type of surgical procedure (laparoscopy or laparotomy).

Ethics and dissemination: This research has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.

Trial registration number: EudraCT 2022-003262-20 and Clinical trial NCT05755789.

Keywords: Anti-Bacterial Agents; Colorectal surgery; Infection control.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Consort diagram of the PROPHYLOXITIN study.
See this image and copyright information in PMC

References

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