Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Infection; Anti-bacterial Agents; Mammaplasty; Prophylaxis; Plastic Surgery
• Intervention / Treatment: Drug: Cephazolin; Other: Sterile saline

• Study Type: Interventional
• Enrollment (Anticipated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela F Veiga, MD, PhD; Phone Number: 3054 55-11-55764848; Email: danielafveiga@gmail.com
• Study Contact Backup: Name: Joel Veiga-Filho, MD, PhD; Phone Number: 55-35-34232502; Email: veigafilhoj@gmail.com

Study Locations

• Brazil
  • MG
    • Pouso Alegre, MG, Brazil, 37550000
      • Recruiting
      • Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí
      • Contact: Joel Veiga-Filho, MD, PhD; Phone Number: 55-35-34232502; Email: veigafilhoj@gmail.com
      • Contact: Daniela F Veiga, MD, PhD; Phone Number: 55-35-34492199; Email: danielafveiga@gmail.com
      • Principal Investigator: Joel Veiga-Filho, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cephazolin; Patients will receive antibiotics (1g cephazolin) intravenously at the anesthestic induction and every 6 hours for 24 hours	Drug: Cephazolin; Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and postoperatively every 6 hours, for 24 hours.
Placebo Comparator: Sterile saline; Patients will receive antibiotics (cephazolin) only at the anesthesia induction, and sterile saline intravenously every 6 hours for 24 hours	Other: Sterile saline; Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and intravenous sterile saline postoperatively, every 6 hours, for 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Daniela Francescato Veiga
• Investigators: Study Chair: Daniela F Veiga, MD, PhD, Federal University of São Paulo

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study Protocol

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: PosDoc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No