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

NCT ID: NCT01845363

Last Updated: 2013-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cefazolin

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).

Group Type OTHER

Cefazolin used in antimicrobial prophylaxis

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Rafael Anlicoara

Master´s degree

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael Anlicoara, MD

Role: PRINCIPAL_INVESTIGATOR

UFPE

Alvaro AB Ferraz, PhD

Role: STUDY_CHAIR

UFPE - Hospital das Clínicas

José L de Lima Filho, PhD

Role: STUDY_DIRECTOR

Laboratory of Immunopathology Keiso Asami(LIKA) - UFPE

Locations

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Universidade Federal de Pernambuco - Hospital das Clínicas

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Cefa01

Identifier Type: -

Identifier Source: org_study_id

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