Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty

NCT04079686 | Completed

• 1 other identifier: PosDoc
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plastic Surgery; Mammaplasty; Anti-bacterial Agents; Prophylaxis; Wound Infection

Outcome Measures

Primary Outcomes (1)

• Number of patients with surgical site infection (SSI)

  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.

  30 days

Study Arms (2)

Cephazolin

EXPERIMENTAL

Patients will receive antibiotics (1g cephazolin) intravenously at the anesthestic induction and every 6 hours for 24 hours

Drug: Cephazolin

Sterile saline

PLACEBO COMPARATOR

Patients will receive antibiotics (cephazolin) only at the anesthesia induction, and sterile saline intravenously every 6 hours for 24 hours

Other: Sterile saline

Interventions

Cephazolin DRUG

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

Cephazolin

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.

Sterile saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniela Francescato Veiga: lead

Study Sites (1)

Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

Related Publications (2)

• Veiga DF, da Silva Garcia E, Moreira-Filho JW, de Mattos Andrade EB, Juliano Y, Veiga-Filho J, Ferreira LM. Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial. Trials. 2020 Jul 2;21(1):605. doi: 10.1186/s13063-020-04539-0.

  PMID: 32616026 BACKGROUND

• Veiga DF, Garcia ES, Veiga-Filho J, Fialho SV, Fortunato Borges AS, Dornelas GV, Machado AA, Felix GAA, Ferreira LM. Single-Dose versus 24-Hour Antibiotic Prophylaxis in Reduction Mammaplasty: A Randomized Controlled Trial. Plast Reconstr Surg. 2025 Dec 1;156(6):835-842. doi: 10.1097/PRS.0000000000012263. Epub 2025 Aug 25.

  PMID: 40857697 DERIVED

Related Links

• Study Protocol

MeSH Terms

Conditions

Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Daniela F Veiga, MD, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: August 4, 2019
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)