Antibiotic Prophylaxis in Bariatric Surgery With Cefazolin: Concentration in Adipose Tissue

Obesity Clinical Trial

Official title:

Antibiotic Prophylaxis in Bariatric Surgery With Continuous Infusion of Cefazolin: Determination of Concentration in Adipose Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845363
• Other study ID #: Cefa01
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2013
• Last updated: April 29, 2013
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2013
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at the beginning and end of surgery, were analyzed using high performance liquid chromatography.

Some published studies suggest that the dose of 2g does not supply the minimum inhibitory concentration for principal causal agents of surgical site infection.

To determine the concentration of Cefazolin in adipose tissue of patients undergoing bariatric surgery and to evaluate the relationship between concentrations obtained and body mass index (BMI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• body mass index greater than 35 and less than 50kg/m2

Exclusion Criteria:

• Hypotension during surgery with use of vasoactive drugs

• renal disfunction (creatinine >1.5 mg/dL)

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Cefazolin used in antimicrobial prophylaxis
Cefazolin administered a first dose of 2g in anesthetic induction, followed by continuous dosage of 1g diluted in 250mL of saline solution for two hours. Two samples of subcutaneous tissue were collected for analysis: the first soon after the incision, and a second before skin synthesis. The samples were processed by HPLC.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco - Hospital das Clínicas	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dosage of Cefazolin in adipose tissue during bariatric surgery		eight months