Antibiotics After Breast Reduction:Clinical Trial With Randomization

Phase 2

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: Placebo; Drug: Cephalexin

• Registration Number: NCT02569866
• Lead Sponsor: Federal University of São Paulo

Brief Summary

This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-10-04
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Primary Completion: 2016-05
• Study Completion: 2016-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Surgical site infection in the postoperative of reduction mammaplasty.	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.

Trial Locations

Locations (1)

Hospital das Clínicas Samuel Libanio; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil