Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty
Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
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.