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Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
Sponsor: Poitiers University Hospital
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
Conditions
Interventions
Loading bolus of cefoxitin
Cefoxitin \[2g\] before incision
Intermittent cefoxitin
Additional bolus of cefoxitin \[1g\] every 2 hours until the end of surgical closure
Continuous infusion of placebo
Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure
Continuous infusion of cefoxitin
Continuous infusion of cefoxitin \[0.5g/h\] from the end of the loading bolus until the end of surgical closure
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