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
  Purpose

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.


Condition Intervention Phase
Bariatric Surgery
Drug: Cefazoline
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery, an Open Label, Prospective, Single Center Trial

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 133
Study Start Date: March 2012
Arms Assigned Interventions
Experimental: Cefazoline Drug: Cefazoline
Injection of CEFAZOLINE (4 grams) 30-60 min before skin incision. A second injection will performed every 4 hours during the surgery

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537380

Contacts
Contact: Romain Dumont, MD romain.dumont@chu-nantes.fr
Contact: Antoine Roquilly, MD antoine.roquilly@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Romain Dumont, MD       romain.dumont@chu-nantes.fr   
Sub-Investigator: Karim Asehnoune, MD-PuPh         
Sub-Investigator: Romain Dumont, MD         
Sub-Investigator: Corinne Lejus, MD-PuPh         
Sub-Investigator: Eric Letessier, MD         
Principal Investigator: Antoine Roquilly, MD         
Sub-Investigator: Sylvie Vrignaud, MD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Romain Dumont, MD Nantes Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01537380     History of Changes
Other Study ID Numbers: BRD11/6-R
Study First Received: February 17, 2012
Last Updated: April 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 20, 2014