Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery

Bariatric Surgery Clinical Trial

— Cefasleeve  

Official title:

Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery, an Open Label, Prospective, Single Center Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537380
• Other study ID #: BRD/11/06-R
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2012
• Last updated: July 18, 2017
• Start date: March 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Drug:
• Cefazoline
Injection of CEFAZOLINE (4 grams) 30-60 min before skin incision. A second injection will performed every 4 hours during the surgery

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue concentration of cefazolin in the superficial subcutaneous fat during the surgical procedure		At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Secondary	Cefazolin tissue concentrations in fatty deep peri gastric tissue throughout the intervention		At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Secondary	Kinetics of tissue concentrations of the superficial subcutaneous fat during surgery in patients with BMI < 50 and patients with BMI > 50		At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Secondary	Kinetics of tissue concentrations of the deep fat peri gastric during surgery in patients with BMI < 50 and patients with BMI > 50		At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Secondary	Kinetics of plasma concentrations during surgery in each group		At the time of incision, at 15, 30, 60 minutes of operation, and at the closure
Secondary	Number of SSI following the surgery.		Within 30 days post-surgery
Secondary	Area Under Curve (AUC) of cefazolin plasma kinetics for each group		Surgical incision,15,30,60 minutes post-incision, surgical closure