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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05755789

Acronym

PROPHYLOXITIN

Enrollment

2000

Registered

2023-03-06

Start date

2023-06-22

Completion date

2025-06-30

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prophylaxis, Colorectal Surgery

Keywords

cefoxitin

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

Interventions

DRUGLoading bolus of cefoxitin

Cefoxitin \[2g\] before incision

DRUGIntermittent cefoxitin

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

DRUGContinuous infusion of placebo

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

DRUGContinuous infusion of cefoxitin

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

DRUGIntermittent placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactMatthieu BOISSON, MD-PhD

matthieu.boisson@chu-poitiers.fr+33549444635

Backup ContactNadia TEIXEIRA

nadia.teixeira@chu-poitiers.fr0549444444

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026