Postoperative Antibiotics Following Primary and Secondary Breast Augmentation

• Status: Not yet recruiting
• Trial end date: 2024-07-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Cefazolin; Cephalexin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

Inclusion Criteria:

• Age 18 year or older

• Participants undergoing primary breast augmentation with subglandular or submuscular implants

• Participants undergoing breast augmentation-mastopexy with subglandular or submuscular implants

• Participants undergoing secondary breast augmentation with subglandular or submuscular implants (i.e. patients undergoing implant exchange secondary to capsular contracture and implant rupture)

Exclusion Criteria:

• Refusal or inability to obtain consent from participants

• Participants with biopsy-proven breast cancer

• Participants undergoing expander-based breast reconstruction

• Participants undergoing autologous flap breast reconstruction

• Participants with history of chest radiation

• Participants with active infection at the time of surgery

• Participants who fail to take the placebos or antibiotics provided in the study for any reason

• Participants who miss postoperative visits

• Participants who withdraw consent at any stage of the study