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

NCT05755789 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2024-04-23

No results posted yet for this study

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

Conditions

  • Antibiotic Prophylaxis
  • Colorectal Surgery

Interventions

DRUG

Loading bolus of cefoxitin

Cefoxitin \[2g\] before incision

DRUG

Intermittent cefoxitin

Additional bolus of cefoxitin \[1g\] every 2 hours until the end of surgical closure

DRUG

Continuous infusion of placebo

Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure

DRUG

Continuous infusion of cefoxitin

Continuous infusion of cefoxitin \[0.5g/h\] from the end of the loading bolus until the end of surgical closure

DRUG

Intermittent placebo

Additional bolus of placebo every 2 hours until the end of surgical closure

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-22
Primary Completion
2025-05-31
Completion
2025-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05755789 on ClinicalTrials.gov