Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery

Phase 4

Completed

• Conditions: Bariatric Surgery
• Interventions: Drug: Cefazoline

• Registration Number: NCT01537380
• Lead Sponsor: Nantes University Hospital

Brief Summary

With 6.5 million obese recorded in France in 2009, obesity is a major public health: it is a chronic disease associated with many respiratory, cardiac, metabolic, musculoskeletal complications. The risk of mortality and morbidity are directly proportional to the importance of overweight and medical treatment alone is only moderately effective weight loss. Bariatric surgery is the only treatment with proven efficacy in patients with a body mass index above 40 kg/m2. As with any surgery, there is a risk of surgical site infection (SSI). The SSI are the third most common nosocomial infection after urinary tract infections and airway. The fight against the ISO requires the administration of antibiotic prophylaxis acting on the main bacteria found in bariatric surgery. There are several studies in the literature interested in the dose of cefazolin in bariatric surgery. However, no published pharmacokinetic studies defines an optimal dose to obtain tissue and plasmatic concentrations of cefazolin higher than minimum inhibitory concentrations of the main germs encountered in these surgery. Only empirical recommendations are published, including the SFAR and the National Institute of Health in 2010. This study aims to determine whether the dose of 4 grams of cefazolin can achieve these goals of concentration and estimate an injection time of preoperative ideal for an adequate tissue concentration at the time of the incision.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-23
• Study Start: 2012-03
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• Male or female, aged > 18 years.
• BMI ≥ 40 and ≤ 65 kg/m2.
• The patient has given informed consent in writing.

Exclusion Criteria

• Age less than 18 years and above 70 years.
• Major Trust.
• Pregnancy.
• Moderate to severe renal insufficiency or clearance creatinine clearance <60 ml / min
• Hypersensitivity to cephalosporins and beta-lactams.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cefazoline	Cefazoline	-

Primary Outcome Measures

Name	Time	Method
Tissue concentration of cefazolin in the superficial subcutaneous fat during the surgical procedure	At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)

Secondary Outcome Measures

Name	Time	Method
Cefazolin tissue concentrations in fatty deep peri gastric tissue throughout the intervention	At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Kinetics of tissue concentrations of the superficial subcutaneous fat during surgery in patients with BMI < 50 and patients with BMI > 50	At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Kinetics of tissue concentrations of the deep fat peri gastric during surgery in patients with BMI < 50 and patients with BMI > 50	At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Kinetics of plasma concentrations during surgery in each group	At the time of incision, at 15, 30, 60 minutes of operation, and at the closure
Number of SSI following the surgery.	Within 30 days post-surgery
Area Under Curve (AUC) of cefazolin plasma kinetics for each group	Surgical incision,15,30,60 minutes post-incision, surgical closure

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France