Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial

BACKGROUND: Reduction mammaplasty is among the most commonly performed procedures in plastic surgery. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. This trial aims to compare the influence of the use of prophylatic antibiotics as a single dose or for 24 h on surgical site infection rates following reduction mammaplasty. METHODS: Randomized trial of non-inferiority, with two parallel groups. A total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. Patients will be randomly allocated to the placebo group that will receive antibiotics only at the anesthesia induction (n = 73) or to the antibiotics group that will receive antibiotics at the anesthesia induction and for 24 h (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. DISCUSSION: Previous studies have demonstrated a decrease in infection rates after reduction mammaplasty when antibiotic prophylaxis was used, compared to the use of no antibiotics. However, the duration of antibiotic prophylaxis remains a point to be clarified. This study will test the hypothesis that maintaining the use of antibiotics for 24 h does not reduce infection rates compared to the use of a single preoperative dose. TRIAL REGISTRATION: Clinicaltrials.gov NCT04079686. Registered on September 6, 2019.