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Completed

NCT Number: NCT01537380

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cefazoline

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. Number of SSI following the surgery.

    Time frame: Within 30 days post-surgery

  6. Area Under Curve (AUC) of cefazolin plasma kinetics for each group

    Time frame: Surgical incision,15,30,60 minutes post-incision, surgical closure

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: Cefasleeve

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 23, 2012
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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