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
Poitiers University Hospital
2,000 participants
Jun 22, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria2
- Adult patients (≥18 years)
- Undergoing colorectal surgery (predictable duration > 90 min)
Exclusion Criteria4
- 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
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Interventions
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
Locations(19)
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NCT05755789