Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial.

[BACKGROUND] The role of antibiotics in surgical procedures where the risk of surgical site infection (SSI) is low remains uncertain. There is, to date, no evidence to justify the routine use of antibiotics in postoperative reduction mammaplasty. The aim of this study is to evaluate the effect of postoperative antibiotic treatment on the occurrence of SSI after breast reduction surgery.

[METHODS] This is a double-blind randomized clinical trial with 124 breast hypertrophy patients allocated to two treatment groups: antibiotic (n = 62) and placebo (n = 62). All patients will undergo reduction mammoplasty, performed by the same surgical team. The surgeons will raise the nipple-areola complex by the superomedial pedicle technique. The patients will receive antibiotics intravenously during anesthetic induction and every 6 hours thereafter during their 24-hour hospital stay. During discharge from the hospital, each patient will receive a numbered package containing either cephalexin or placebo capsules and will be directed to take one capsule every 6 hours for 7 days. Neither the surgery team nor the patients will know the contents of the capsules. 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.

[DISCUSSION] Due to the variety of risk factors for SSI and limited case studies, conclusions regarding the effect of antibiotics on the occurrence of SSIs following reduction mammaplasty are potentially biased. In recent studies, perioperative antibiotic prophylaxis was effective in preventing infection and is therefore recommended in clinical practice. However, antibiotic use in the postoperative period still remains controversial.

[TRIAL REGISTRATION] Clinicaltrials.gov Identifier: NCT02569866 . Registered on 4 October 2015.