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Local Antibiotics for Breast Implants — BREAST-AB  

Implant Complication Clinical Trial

Official title:
Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial (The BREAST-AB Trial)

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

Clinical Trial Details
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
View Details
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