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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04731025
Study type Interventional
Source Rigshospitalet, Denmark
Contact Mikkel Herly, MD, Ph.D.
Phone +45 27598919
Email mikkel.herly@regionh.dk
Status Recruiting
Phase Phase 3
Start date January 27, 2021
Completion date January 27, 2026

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