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NCT05755789
Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
Conditions: Antibiotic Prophylaxis, Colorectal Surgery
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 2000
Sponsor: Poitiers University Hospital
Location: France
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 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-lactamsPatients 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
Source: ClinicalTrials.gov (NCT05755789). StuddyBuddy aggregates publicly available trial information.