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NCT ID: NCT04834310 Withdrawn - Clinical trials for Surgical Site Infection

Postoperative Antibiotics Following Primary and Secondary Breast Augmentation

Start date: April 1, 2021
Phase: Phase 4
Study type: Interventional

Postoperative antibiotics are routinely used for implant-based breast augmentation at the investigators' institution. From 2017-2019, the investigators' institution has conducted approximately 270 primary and secondary breast augmentation procedures. Current plastic surgery literature does not provide recommendations for antibiotic prophylaxis following implant-based breast procedures. Despite controversy surrounding their utility during the postoperative course, postoperative antibiotics have become commonplace for many plastic surgeons. To date, strong scientific evidence supporting this practice is minimal and based largely on anecdotal evidence and limited studies, including poorly controlled retrospective and non-blinded prospective series. The goal of this study is to conduct a prospective randomized trial to assess whether extended antibiotic prophylaxis is necessary to prevent infection and long-term complications (e.g. capsular contracture) in patients undergoing augmentation mammoplasty with implants. The investigators' anticipate that extended antibiotic prophylaxis is not required. The rationale for discontinuing postoperative antibiotics is based on the following: (1) a single dose of preoperative intravenous antibiotics has been demonstrated to be sufficient prophylaxis for most breast surgeries and (2) there are patient safety concerns associated with prolonged antimicrobial use such as the development of resistant bacterial strains and clostridium-related infections. Concrete evidence that extended antibiotic prophylaxis is not required would encourage plastic surgeons to practice better antibiotic stewardship and help stymie the rise of drug-resistant organisms.