Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty

Setting: Translacional Surgery Graduation Program - Universidade Federal de São Paulo and Hospital das Clínicas Samuel Libânio - Universidade do Vale do Sapucaí. Background: Breast reduction is one of the most performed plastic surgery procedures. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. Objective: To compare the influence of the use of prophylatic antibiotics as a single dose or for 24 hours on surgical site infection rates following reduction mammaplasty. Methods: Randomized trial of non-inferiority, with two parallel groups, double blinded. A total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. Patients will be randomly allocated to group A, that will receive antibiotics only at the anesthesia induction (n=73), or to group B, that will receive antibiotics at the anesthesia induction and for 24 hours (n=73). None of the patients will receive antibiotics after hospital discharge. Patients will be followed-up weekly, for 30 days, regarding surgical site infection. The Centers for Disease Control and Prevention criteria will be applied. A statistical analysis of the data will be performed.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plastic Surgery Anti-bacterial Agents Infections Mammaplasty Prophylaxis Wound Infection

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí

Pouso Alegre, Minas Gerais, 37550000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 and 60 years of age
body mass index (BMI) between 19 and 30 kg/m2
breast hypertrophy according to the criteria of Sacchini et al. and Franco and Rebello

Exclusion criteria

patients who had previously undergone another surgical procedure of the breast
patients who have been diagnosed with a breast pathology
smokers
patients who had a child or breastfed within the last year
patients with uncontrolled comorbidities, such as arterial hypertension or diabetes
use of immunosuppressants
patients who had any infection during the follow-up period, requiring the use of antibiotics
patients who present any adverse effects due to the antibiotics during the study
patients who miss follow-up assessments
patients who withdraw their consent at any time

Treatment and study plan

Cephazolin

Drug

Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and postoperatively every 6 hours, for 24 hours.

sterile saline

Other

Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and intravenous sterile saline postoperatively, every 6 hours, for 24 hours.

Primary outcomes

Number of patients with surgical site infection (SSI)

Time frame: 30 days

Patients will be monitored for the occurrence of SSI once weekly during the first 30 days following hospital discharge by a single surgeon who is blinded to their treatment group. SSI will be evaluated based on the definition adopted by the Centers for Disease Control and Prevention.

Sponsors and collaborators

Lead sponsor

Daniela Francescato Veiga

Other

Registry information

Official study title

Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty: a Randomized Clinical Trial

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Sep 6, 2019
Registry last updated: Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed