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

Study Overview
=================
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 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

Official Title
-----------------
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

Conditions
-----------------
Antibiotic Prophylaxis, Colorectal Surgery

Intervention / Treatment
-----------------
* Drug: Loading bolus of cefoxitin
* Drug: Intermittent cefoxitin
* Drug: Continuous infusion of placebo
* Drug: Continuous infusion of cefoxitin
* Drug: Intermittent placebo


Participation Criteria
=================
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-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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (innovative administration scheme)<br>Continuous infusion of cefoxitin + Intermittent placebo | Drug: Loading bolus of cefoxitin<br>* Cefoxitin [2g] at least 30 min before incision<br>Drug: Continuous infusion of cefoxitin<br>* Continuous infusion of cefoxitin [0.5g/h] from the end of the loading bolus until the end of surgical closure<br>Drug: Intermittent placebo<br>* Additional bolus of placebo every 2 hours until the end of surgical closure<br>|
| Active Comparator: Control group (recommended administration scheme)<br>Intermittent cefoxitin + Continuous infusion of placebo | Drug: Loading bolus of cefoxitin<br>* Cefoxitin [2g] at least 30 min before incision<br>Drug: Intermittent cefoxitin<br>* Additional bolus of cefoxitin [1g] every 2 hours until the end of surgical closure<br>Drug: Continuous infusion of placebo<br>* Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Proportion of patients with any surgical site infection according to the CDC criteria | within 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cefoxitin