Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty

Last updated: February 25, 2025
Sponsor: Daniela Francescato Veiga
Overall Status: Completed

Phase

N/A

Condition

Breast Reconstruction

Treatment

Sterile saline

Cephazolin

Clinical Study ID

NCT04079686
PosDoc
  • Ages 18-60
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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 andRebello

Exclusion

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 ofantibiotics

  • 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

Study Design

Total Participants: 146
Treatment Group(s): 2
Primary Treatment: Sterile saline
Phase:
Study Start date:
August 04, 2019
Estimated Completion Date:
October 28, 2024

Connect with a study center

  • Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí

    Pouso Alegre, MG 37550000
    Brazil

    Site Not Available

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