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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,000
Cefoxitin \[2g\] before incision
Additional bolus of cefoxitin \[1g\] every 2 hours until the end of surgical closure
Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure
Continuous infusion of cefoxitin \[0.5g/h\] from the end of the loading bolus until the end of surgical closure
Additional bolus of placebo every 2 hours until the end of surgical closure
Centre Hospitalier de Poitiers
Poitiers, Vienne, France
RECRUITINGCHU Angers
Angers, France
RECRUITINGHopital privé Arras les Bonnettes
Arras, France
RECRUITINGCHU Caen
Caen, France
RECRUITINGCHU Clermont Ferrand
Clermont-Ferrand, France
RECRUITINGCHU Grenoble
Grenoble, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGHospices Civils Lyon
Lyon, France
RECRUITINGInstitut Paoli Calmettes
Marseille, France
RECRUITINGCHRU Nancy
Nancy, France
RECRUITING...and 9 more locations
Surgical site infection
Proportion of patients with any surgical site infection according to the CDC criteria
Time frame: within 30 days after surgery
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