Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery (Cefasleeve)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01537380
First received: February 17, 2012
Last updated: April 4, 2014
Last verified: April 2014

February 17, 2012
April 4, 2014
March 2012
Not Provided
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) ] [ Designated as safety issue: No ]
Tissue concentration of cefazolin in the superficial subcutaneous fat during the surgical procedure [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01537380 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of SSI following the surgery. [ Time Frame: Within 30 days post-surgery ] [ Designated as safety issue: Yes ]
  • Area Under Curve (AUC) of cefazolin plasma kinetics for each group [ Time Frame: Surgical incision,15,30,60 minutes post-incision, surgical closure ] [ Designated as safety issue: No ]
  • Determine if the cefazolin tissue concentrations in fatty deep peri gastric tissue are greater than 8 micrograms / gram of fat tissue throughout the intervention
  • Assess and compare the kinetics of tissue concentrations of the superficial subcutaneous fat during surgery between patients with BMI < 50 and patients with BMI > 50
  • Assess and compare the kinetics of tissue concentrations of the deep fat peri gastric during surgery patients with BMI < 50 and patients with BMI > 50
  • Assess and compare the kinetics of plasma concentrations during surgery between the 2 groups.
  • Describe the number of SSI following the surgery.
  • Pharmacokinetic Analysis
Not Provided
Not Provided
 
Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery
Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery, an Open Label, Prospective, Single Center Trial

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Bariatric Surgery
Drug: Cefazoline
Injection of CEFAZOLINE (4 grams) 30-60 min before skin incision. A second injection will performed every 4 hours during the surgery
Experimental: Cefazoline
Intervention: Drug: Cefazoline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
133
Not Provided
Not Provided

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.
Both
18 Years to 70 Years
No
Contact: Romain Dumont, MD romain.dumont@chu-nantes.fr
Contact: Antoine Roquilly, MD antoine.roquilly@chu-nantes.fr
France
 
NCT01537380
BRD11/6-R
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Romain Dumont, MD Nantes Hospital
Nantes University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP