Postoperative Antibiotics Following Primary and Secondary Breast Augmentation

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.

Conditions

• Surgical Site Infection
• Capsular Contracture Associated With Breast Implant
• Antibiotic Resistant Infection
• Antibiotic Side Effect

Interventions

DRUG

Cefazolin

All patients will receive an intraoperative dose of IV Cefazolin 2 g (re-dose after 4 hours) or IV Clindamycin 600mg (re-dose after 6 hours) for penicillin allergic patients.

DRUG

Cephalexin

The experimental group will receive a postoperative 5-day course of Cephalexin 500 mg QID or Clindamycin 300 mg QID for penicillin allergic patients. All capsules will be encapsulated with size 00 dark-colored capsules compounded by the UCLA Investigational Pharmacy.

OTHER

Placebo

The placebo group will receive a postoperative 5-day course of placebos (sugar capsules). All capsules will be encapsulated with size 00 dark-colored capsules compounded by the UCLA Investigational Pharmacy.

Sponsors & Collaborators

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Karie Villanueva, MD · University of California, Los Angeles

• Jaco Festekjian, MD · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2024-05-30

Completion

2024-07-30

FDA Drug

Yes