Antibiotics After Breast Reduction:Clinical Trial With Randomization

April 18, 2018 updated by: Edgard da Silva Garcia, Federal University of São Paulo
This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prevention of SSI is important due to its morbidity, longer hospital stays and higher costs. In many surgical procedures where the risk of infection is relatively low and the postoperative infection can be treated properly, the role of antibiotics is not clear.

Despite the lack of evidence from prospective randomized controlled trials of evaluation, the use of antibiotics in plastic surgery is widespread in order to offer the highest safety standards patients.

The breast reduction is defined as "clean surgery" with a lower infection rate to 3.4%. Thus, the antibiotic is not recommended. However, studies have shown a real rate of infection associated with procedures ranging from 4-36%.

Thus, this trial was designed to verify the role of antibiotics in reduction mammaplasty.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Pouso Alegre, Minas Gerais, Brazil, 37553079
        • Hospital das Clinicas Samuel Libanio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Breast hypertrophy
  • Body mass index between 19 to 30 kg/m2

Exclusion Criteria:

  • Patients undergoing a surgical procedure in the breast
  • Diagnosis of breast pathology
  • Smoking
  • Childbirth or lactation less than a year
  • Uncontrolled comorbidities
  • Use of immunosuppressive drugs
  • Misuse of capsules supplied
  • Absence during the weekly follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antibiotics Group
Capsules containing cephalexin/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.
Drug: Cephalexin
Capsules containing cephalexin/500mg
Placebo Comparator: Placebo Group
Capsules containing placebo/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.
Drug: Placebo
Capsules containing placebo/500mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection in the postoperative of reduction mammaplasty.
Time Frame: 30 days postoperatively
After surgery, the patients will be followed for 30 days and surgical site infection rates will be observed in both groups, according to the CDC criteria.
30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Universidade do Vale do Sapucai

Investigators

  • Study Chair: Lydia M Ferreira, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 4, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESG180402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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