Status:
WITHDRAWN
Postoperative Antibiotics Following Primary and Secondary Breast Augmentation
Lead Sponsor:
University of California, Los Angeles
Conditions:
Surgical Site Infection
Capsular Contracture Associated With Breast Implant
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 pri...
Detailed Description
The investigators will perform a randomized, double-blinded, placebo-controlled trial at University of California Los Angeles Ronald Reagan Medical Center for patients undergoing primary and secondary...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04834310
Start Date
April 1 2021
End Date
July 30 2024
Last Update
September 14 2022
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