Antibiotics After Breast Reduction:Clinical Trial With Randomization

Federal University of São Paulo124 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

124

Conditions

Surgical Site Infection

Interventions

CephalexinDRUG

Capsules containing cephalexin/500mg

PlaceboDRUG

Capsules containing placebo/500mg

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital das Clínicas Samuel Libanio

Pouso Alegre, Minas Gerais, Brazil

Outcomes

Primary Outcomes

Surgical site infection in the postoperative of reduction mammaplasty.

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.

Time frame: 30 days postoperatively

Data from ClinicalTrials.gov

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