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

NCT01845363 | Completed Phase 4

• 1 other identifier: Cefa01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity

Keywords

Obesity; Bariatric surgery; Cefazolin; antimicrobial prophylaxis; administration and dosage

Outcome Measures

Primary Outcomes (1)

• dosage of Cefazolin in adipose tissue during bariatric surgery

  eight months

Study Arms (1)

Cefazolin

OTHER

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 High Pressure Liquid Chromatography (HPLC).

Drug: Cefazolin used in antimicrobial prophylaxis

Interventions

Cefazolin used in antimicrobial prophylaxis DRUG

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.

Cefazolin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Hypotension during surgery with use of vasoactive drugs
• renal disfunction (creatinine \>1.5 mg/dL)

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco - Hospital das Clínicas

Recife, Pernambuco, 50670901, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rafael Anlicoara, MD

  UFPE

  PRINCIPAL INVESTIGATOR

• Alvaro AB Ferraz, PhD

  UFPE - Hospital das Clínicas

  STUDY CHAIR

• José L de Lima Filho, PhD

  Laboratory of Immunopathology Keiso Asami(LIKA) - UFPE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master´s degree

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 3, 2013
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: May 1, 2012
• Last Updated: May 3, 2013

Record last verified: 2013-04

Locations

BR (1)