NCT01537380

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

3.1 years

First QC Date

February 17, 2012

Last Update Submit

July 18, 2017

Conditions

Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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

  • Number of SSI following the surgery.

    Within 30 days post-surgery

  • +1 more secondary outcomes

Study Arms (1)

Cefazoline

EXPERIMENTAL
Drug: Cefazoline

Interventions

CefazolineDRUG

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

Cefazoline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged \> 18 years.
  • BMI ≥ 40 and ≤ 65 kg/m2.
  • The patient has given informed consent in writing.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (1)

  • Cinotti R, Dumont R, Ronchi L, Roquilly A, Atthar V, Gregoire M, Planche L, Letessier E, Dailly E, Asehnoune K. Cefazolin tissue concentrations with a prophylactic dose administered before sleeve gastrectomy in obese patients: a single centre study in 116 patients. Br J Anaesth. 2018 Jun;120(6):1202-1208. doi: 10.1016/j.bja.2017.10.023. Epub 2017 Dec 6.

    PMID: 29793587DERIVED

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Romain Dumont, MD

    Nantes Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 23, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

FR(1)