NCT05755789

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Antibiotic Prophylaxis
• Colorectal Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-22
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2023-03-06
• Last updated: 2024-04-23

Locations

19 sites across 1 country: France