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CompletedNCT01845363Updated May 3, 2013

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

A Phase 4 interventional study of Cefazolin used in antimicrobial prophylaxis in Obesity, sponsored by Universidade Federal de Pernambuco. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-05-03.

Sponsored by Universidade Federal de Pernambuco · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • Bariatric surgery
  • Cefazolin
  • antimicrobial prophylaxis
  • administration and dosage
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 18 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

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Lead sponsor

Universidade Federal de Pernambuco is the lead sponsor of 161 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hypotension during surgery with use of vasoactive drugs
  • renal disfunction (creatinine >1.5 mg/dL)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
18 participants (actual)

Study arms

  • Other
    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).

    Drug: Cefazolin used in antimicrobial prophylaxis

Interventions

  • DrugCefazolin 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.

06

What researchers measure

Primary outcomes

  1. dosage of Cefazolin in adipose tissue during bariatric surgery

    Time frame: eight months

07

Study locations

1 site
  • Universidade Federal de Pernambuco - Hospital das Clínicas
    Recife, Pernambuco 50670901, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01845363
Lead sponsor
Universidade Federal de Pernambuco
Responsible party
Rafael Anlicoara (Master´s degree, Universidade Federal de Pernambuco) — Principal investigator
First posted
May 3, 2013
Start date
Jun 2011
Primary completion
Oct 2011
Completion
May 2012
Last update
May 3, 2013

Study contacts

Rafael Anlicoara, MD
principal investigator · UFPE
Alvaro AB Ferraz, PhD
study chair · UFPE - Hospital das Clínicas
José L de Lima Filho, PhD
study director · Laboratory of Immunopathology Keiso Asami(LIKA) - UFPE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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