Local Antibiotics for Breast Implants (BREAST-AB)
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- STATUS
- Recruiting
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- End date
- Jul 27, 2025
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- participants needed
- 1003
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- sponsor
- Mikkel Herly
Summary
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.
Description
The BREAST-AB Trial will include women undergoing breast reconstruction with implants. The objective is to determine the efficacy of local antibiotics in decreasing all-cause implant explantation. Participants will be randomized to local application of placebo or gentamicin, vancomycin and cefazolin in a saline solution onto the implant and the dissected breast pocket. All patients undergoing unilateral breast reconstruction will be randomized to the trial drug or placebo in a ratio of 1:1. All patients undergoing bilateral reconstruction will be randomized to the trial treatment on one of their breasts and placebo to the contralateral breast. A total number of 1274 of breasts undergoing breast reconstruction will be included in the trial.
Details
| Condition | Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion, Antibiotic Side Effect |
|---|---|
| Treatment | Placebo, Gentamicin, Cefazolin and Vancomycin |
| Clinical Study Identifier | NCT04731025 |
| Sponsor | Mikkel Herly |
| Last Modified on | 9 July 2022 |
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