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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poitiers University Hospital
• Treatments: Cefotaxime; Cefoxitin

Criteria

Inclusion Criteria:

• Adult patients (≥18 years)

• Undergoing colorectal surgery (predictable duration > 90 min)

Exclusion Criteria:

• Patients with known history of hypersensitivity to cefoxitin or others beta-lactams

• Patients with severe obesity (defined by a body mass index greater than 35 kg/m2)

• Patients with severe renal insufficiency (clearance creatinine < 30ml/min)

• Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis