ABSTRACT
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.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Antibiotic Prophylaxis/methods , Mammaplasty/adverse effects , Surgical Wound Infection/prevention & control , Brazil , Female , Humans , Randomized Controlled Trials as TopicABSTRACT
INTRODUCTION: BREAST-Q™ is a patient-reported outcomes survey instrument with a specific module that evaluates breast reduction surgery. It allows assessment of patient's satisfaction with received treatment and evaluates the impact of surgery on different aspects of the patient's quality of life. This article aims to assess the satisfaction and quality of life of patients who underwent reduction mammaplasty. MATERIALS AND METHODS: Women aged between 18 and 60 years, with a body mass index ranging from 19 to 30 kg/m2, who were already scheduled for reduction mammaplasty, were included in the study. The Brazilian version of the BREAST-Q™ Reduction/Mastopexy Module (preoperative 1.0 and postoperative 1.0 versions) was self-applied preoperatively and 1 and 6 months after the operation. RESULTS: One hundred and seven patients were included in the study and completed the 6-month follow-up. The median age was 33 years, and the median preoperative body mass index was 25 kg/m2. The superomedial pedicle was used in 96.3% of the cases, and the total median weight of the resected breast was 1115 g. There was a significant improvement in the scores of the scales: Psychosocial well-being, Sexual well-being, Physical well-being, and Satisfaction with the breasts compared to the preoperative assessment (p < 0.0001). The scales Satisfaction with the NAC and Satisfaction with the outcome, available only in the postoperative version, demonstrated high satisfaction rates at the two postoperative periods evaluated. CONCLUSION: Reduction mammaplasty improved the quality of life and provided high levels of patient satisfaction with outcomes 1 and 6 months postoperatively. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
