| Title: |
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 |
| Authors: |
Saint-Genis, Quentin; Birckener, Julien; Gourdou, Vincent; Nicolle, Claire; Garnier, Marc; Schwindenhammer, Victor; Hannezo, Cécile; Aveline, Christophe; Cinotti, Raphaël; Puisney, Benjamin; Garot, Matthias; Chevalier, Stéphanie; Aubert, Jean-Sébastien; Wodey, Maxime; Lasocki, Sigismond; Lecoeur, Sylvain; Lagarrigue, Charles, Jean; Li, Anne; Faucher, Marion; Foucher, Yohann; Frasca, Denis; Boisson, Matthieu |
| Contributors: |
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie ); Pharmacologie des anti-infectieux et antibiorésistance U 1070 (PHAR2 Poitiers ); Université de Poitiers = University of Poitiers (UP)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy); Centre Hospitalier Universitaire de Toulouse (CHU Toulouse); CHU Caen Normandie – Centre Hospitalier Universitaire de Caen Normandie (CHU Caen Normandie); Normandie Université (NU); CHU Clermont-Ferrand; CHU de Grenoble-Alpes - Centre Hospitalier Universitaire CHU Grenoble (CHUGA); Centre Léon Bérard Lyon; Hopital Privé Sévigné Cesson-Sévigné, France; methodS in Patients-centered outcomes and HEalth ResEarch (SPHERE); Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nantes Université - UFR des Sciences Pharmaceutiques et Biologiques (Nantes Univ - UFR Pharmacie); Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ); Service d'anesthésie et réanimation chirurgicale Nantes; Hôtel-Dieu-Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); Centre hospitalier Bretagne Atlantique (Morbihan) (CHBA); Hôpital privé les Bonnettes Arras; Clinique mutualiste La Sagesse; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E); Service d'anesthésie et réanimation chirurgicale; Centre Hospitalier Universitaire d'Angers (CHU Angers); Hôpital de Saint-Brieuc Hôpital Yves Le Foll; Centre hospitalier Saint-Brieuc Paimpol Tréguier (CH Saint-Brieuc Paimpol Tréguier); Groupement Hospitalier Territoire d'Armor (GHT Armor)-Groupement Hospitalier Territoire d'Armor (GHT Armor); Centre Hospitalier Universitaire Strasbourg (CHU Strasbourg); Hôpitaux Universitaires de Strasbourg (HUS); Hospices Civils de Lyon (HCL); Institut Paoli-Calmettes (IPC); Fédération nationale des Centres de lutte contre le Cancer (FNCLCC); CIC de Poitiers – Centre d'investigation clinique de Poitiers (CIC 1402) (CIC 1402); Université de Poitiers = University of Poitiers (UP)-Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie )-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| Source: |
EISSN: 2044-6055 ; BMJ Open ; https://hal.science/hal-05115908 ; BMJ Open, 2025, 15 (1), pp.e088306. ⟨10.1136/bmjopen-2024-088306⟩ ; https://bmjopen.bmj.com/content/15/1/e088306 |
| Publisher Information: |
CCSD; BMJ Publishing Group |
| Publication Year: |
2025 |
| Collection: |
Université François-Rabelais de Tours: HAL |
| Subject Terms: |
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Description: |
International audience ; 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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/39880423; PUBMED: 39880423; PUBMEDCENTRAL: PMC11781116 |
| DOI: |
10.1136/bmjopen-2024-088306 |
| Availability: |
https://hal.science/hal-05115908; https://hal.science/hal-05115908v1/document; https://hal.science/hal-05115908v1/file/e088306.full.pdf; https://doi.org/10.1136/bmjopen-2024-088306 |
| Rights: |
https://creativecommons.org/licenses/by-nc/4.0/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.F39D96F7 |
| Database: |
BASE |