Clinical trial NCT04079686: Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty
Official title: Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plastic Surgery
Mammaplasty
Anti-bacterial Agents
Prophylaxis
Wound Infection
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with surgical site infection (SSI)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí
state: MG
Study officials:
affiliation: Federal University of São Paulo
name: Daniela F Veiga, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.