Status:
RECRUITING
Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
Lead Sponsor:
Poitiers University Hospital
Conditions:
Antibiotic Prophylaxis
Colorectal Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ant...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years)
- Undergoing colorectal surgery (predictable duration \> 90 min)
Exclusion
- Patients with known history of hypersensitivity to cefoxitin or others beta-lactams
- Patients with extreme severe obesity (defined by a body mass index greater than 50 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
Key Trial Info
Start Date :
June 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05755789
Start Date
June 22 2023
End Date
June 1 2025
Last Update
April 23 2024
Active Locations (19)
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1
Centre Hospitalier de Poitiers
Poitiers, Vienne, France, 86021
2
CHU Angers
Angers, France
3
Hopital privé Arras les Bonnettes
Arras, France
4
CHU Caen
Caen, France