Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Obese Patients Undergoing BARiatric Surgery (CEFOBAR)

Central Hospital, Nancy, France

Status: Completed

Conditions: Obese; Bariatric Surgery Candidate; Antibiotic Prophylaxis

Treatments: Drug: Serum dosage of antibiotic prophylaxis CEFOXITIN

Study type: Interventional

Funder types: Other

Identifiers

NCT03306290

2017-A01285-48

Details and patient eligibility

About

Obesity is a pandemic problem in modern societies. Bariatric surgery (gastric by-pass and sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality related to obesity. Obesity and bariatric surgery are known to be risk factors of surgical site infections (SSI). The occurrence of SSI increases health cost and the duration of hospitalization. However, an appropriate antibiotic prophylaxis has been shown to reduce SSI. As recommended by several national societies, the antibiotic prophylaxis dose should be increased in the severely obese population. However, this recommendation lies on a low level of evidence. Besides, great disparities regarding obese patient antibiotic prophylaxis exist between countries and adequate doses are still not clearly defined. In France, for instance, the intravenous second generation cephalosporin CEFOXITIN is used for antibiotic prophylaxis in bariatric surgery at the initial loading dose of 4g (2-fold that of non-obese population) at the beginning of surgery.

Obese patients have increased risk of under-dosage due to modification of their pharmacokinetics (fat/lean mass, distribution volume, renal clearance, etc.). Only few studies, all investigating a low amount of patients, evaluated the appropriateness of intraoperative antibiotic prophylaxis dosage of different betalactam and cephalosporin in the obese population. This population was more likely to be under-dosed.

The aim of this study is to analyse the appropriateness of the reference dose of intravenous Cefoxitin used as antibiotic prophylaxis in severely obese patients undergoing bariatric surgery. This will be a 2-year prospective monocentric study held in the University Hospital of Nancy, France. A large group of obese patients (~300) will be included. Serial serum concentration measurements of Cefoxitin will be performed before, during, and at skin closure of the bariatric surgery. This study will give insights in pharmacokinetics of the antibiotic prophylaxis in the obese population and will help to determine the initial dosage and the optimal method for antibiotic prophylaxis administration.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years-old,
• Severely obese patient with a BMI ≥ 35 kg.m-2,
• Scheduled bariatric surgery: gastric by-pass or sleeve gastrectomy,
• Affiliated to social security,
• The patient is able to consent to clinical research and has received all information on the study design/protocol,
• Signed/written informed consent

Exclusion criteria

• Refuse to consent to the study or the patient is unable to consent,
• Allergy/Anaphylaxis to beta-lactam (ß-lactam) antibiotics either proven or suspected,
• Pregnancy,
• Persons deprived of their liberty by judicial or administrative decision,
• Urgent or emergent surgery.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Bariatric surgery candidate

Other group

Description:

Patients included in this study belong to this arm and put up with intervention "Serum dosage of antibiotic prophylaxis CEFOXITIN"

Treatment:

Drug: Serum dosage of antibiotic prophylaxis CEFOXITIN