Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique

Phase 4

Completed

• Conditions: Antibiotic Prophylaxis Surgery

• Registration Number: NCT02703857
• Lead Sponsor: Poitiers University Hospital

Brief Summary

The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.

The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.

This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.

They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.

The primary endpoints are:

* Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin

* Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure

* Urinary concentrations of cefoxitin

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Primary Completion: 2016-09-15
• Study Completion: 2016-09-20
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients who underwent major abdominal surgery whose forseeable time exceeds 4 hours and requires an antibiotic prophylaxis by cefoxitin

Exclusion Criteria

• morbid obesity (BMI > 35 kg/m²)
• severe renal impairment (clearance creatinine < 30ml/min)
• beta lactam hypersensitivity
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total and free plasma of cefoxitin after repeated injections	48 hours
Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections	48 hours
Concentration of cefoxitin in urine after every injection	48 hours

Secondary Outcome Measures

Name	Time	Method
Concentrations of antibiotic in peritoneal fluid	48 hours
Cmax of Cefoxitin	48 hours
Vd of distribution o cefoxitin	48 hours
Area under the curve of plasma and tissue concentration of cefoxitin	48 hours
Clearance of elimination of cefoxitin	48 hours
Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms	48 hours
Clearance of distribution of cefoxitin	48 hours

Trial Locations

Locations (1)

Centre Hospitalier de Poitiers; 🇫🇷 Poitiers, France