Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05755789
PHASE3

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

Sponsor: Poitiers University Hospital

View on ClinicalTrials.gov

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

Official title: Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery: a Multicentre, Double-blind, Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2023-06-22

Completion Date

2025-06

Last Updated

2024-04-23

Healthy Volunteers

No

Interventions

DRUG

Loading bolus of cefoxitin

Cefoxitin \[2g\] before incision

DRUG

Intermittent cefoxitin

Additional bolus of cefoxitin \[1g\] every 2 hours until the end of surgical closure

DRUG

Continuous infusion of placebo

Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure

DRUG

Continuous infusion of cefoxitin

Continuous infusion of cefoxitin \[0.5g/h\] from the end of the loading bolus until the end of surgical closure

DRUG

Intermittent placebo

Additional bolus of placebo every 2 hours until the end of surgical closure

Locations (19)

Centre Hospitalier de Poitiers

Poitiers, Vienne, France

CHU Angers

Angers, France

Hopital privé Arras les Bonnettes

Arras, France

CHU Caen

Caen, France

CHU Clermont Ferrand

Clermont-Ferrand, France

CHU Grenoble

Grenoble, France

Centre Léon Bérard

Lyon, France

Hospices Civils Lyon

Lyon, France

Institut Paoli Calmettes

Marseille, France

CHRU Nancy

Nancy, France

CHU de Nantes

Nantes, France

Hopital Européen Gorges Pompidou

Paris, France

Clinique Mutualiste la Sagesse

Rennes, France

Hôpital Privé Rennais Cesson Sevigné

Rennes, France

CH St Brieuc

Saint-Brieuc, France

CHU St Etienne

Saint-Etienne, France

Hopitaux de Strasbourg

Strasbourg, France

CHU Toulouse Rangueil

Toulouse, France

CH Bretagne Atlantique vannes

Vannes, France