PROPHYLOXITIN-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
- Colorectal surgery
- Registration Number
- 2024-515146-16-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Poitiers
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 2000
Adult patients (≥18 years)
Undergoing colorectal surgery (predictable duration > 90 min)
Patients benefiting from a Social Security system or benefiting from it through a third party
Free subject, without guardianship or curatorship or subordination
Having given their informed consent
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
Participation to another clinical trial aimed at reducing SSI
Patients already previously enrolled in this study
Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)
Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with any SSI within 30 days after surgery. Proportion of patients with any SSI within 30 days after surgery.
- Secondary Outcome Measures
Name Time Method Proportion of patients with each type of SSI (superficial, deep and/or organ–space infection) Proportion of patients with each type of SSI (superficial, deep and/or organ–space infection)
Proportion of patients with surgical reintervention Proportion of patients with surgical reintervention
Proportion of patients with anastomotic leak Proportion of patients with anastomotic leak
Proportion of patients with postoperative complication according to the Dindo and Clavien classification Proportion of patients with postoperative complication according to the Dindo and Clavien classification
Proportion of patients with Clostridium difficile infection Proportion of patients with Clostridium difficile infection
Hospital readmission censored at day 30 Hospital readmission censored at day 30
Unexpected admission to the ICU censored at day 30 Unexpected admission to the ICU censored at day 30
Duration of hospital stay and hospital free days Duration of hospital stay and hospital free days
All-causes mortality All-causes mortality
Proportion of per operative adverse events Proportion of per operative adverse events
Trial Locations
- Locations (18)
Assistance Publique Hopitaux De Paris
🇫🇷Paris, France
CHRU De Nancy
🇫🇷Nancy, France
Centre Hospitalier Universitaire De Saint Etienne
🇫🇷Saint-Etienne, France
Hopital Prive Sevigne
🇫🇷Cesson Sevigne, France
Centre Hospitalier Universitaire De Poitiers
🇫🇷Poitiers, France
Centre Hospitalier Universitaire De Toulouse
🇫🇷Toulouse, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷Grenoble Cedex 9, France
Hospices Civils De Lyon
🇫🇷Lyon Cedex 02, France
Les Hopitaux Universitaires De Strasbourg
🇫🇷Strasbourg Cedex, France
Centre Hospitalier Universitaire De Caen Normandie
🇫🇷Caen Cedex 9, France
Scroll for more (8 remaining)Assistance Publique Hopitaux De Paris🇫🇷Paris, FranceJean-Sébastien AUBERTSite contact0156092596jean-sebastien.aubert@aphp.fr