Bariatric Surgery Candidate Clinical Trial
Official title:
An Evaluation of Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Severely and Morbidly Obese Patients Undergoing BARiatric Surgery (CEFOBAR)
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.
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