A Phase 4 interventional study of Cefazoline in Bariatric Surgery, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-19.
Sponsored by Nantes University Hospital · Phase 4, Interventional, and Other
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.
Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Cefazoline
Injection of CEFAZOLINE (4 grams) 30-60 min before skin incision. A second injection will performed every 4 hours during the surgery
Tissue concentration of cefazolin in the superficial subcutaneous fat during the surgical procedure
Time frame: At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Cefazolin tissue concentrations in fatty deep peri gastric tissue throughout the intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the time of incision, at 15, 30, 60 minutes of operation, and at the closure
Number of SSI following the surgery.
Time frame: Within 30 days post-surgery
Area Under Curve (AUC) of cefazolin plasma kinetics for each group
Time frame: Surgical incision,15,30,60 minutes post-incision, surgical closure
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nantes University Hospital