Local Antibiotics for Breast Implants

Phase 3 Active not recruiting 1003 enrolled Mikkel Herly Aalborg University Hospital · collab Aarhus University Hospital · collab Esbjerg Hospital - University Hospital of Southern Denmark · collab Herlev and Gentofte Hospital · collab Odense University Hospital · collab University of Copenhagen · collab Vejle Hospital · collab Zealand University Hospital · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2021-01-27
Primary completion: 2026-09-26
Completion: 2027-09

Publications

Hemmingsen MN, Larsen A, Weltz TK, Orholt M, Wiberg S, Bennedsen AK, Bille C, Carstensen LF, Jensen LT, Bredgaard R, Koudahl V, Schmidt VJ, Vester-Glowinski P, Holmich LR, Sorensen SJ, Bjarnsholt T, Damsgaard T, Herly M. Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: protocol for a randomised, double-blind, placebo-controlled trial (The BREAST-AB trial). BMJ Open. 2022 Sep 17;12(9):e058697. doi: 10.1136/bmjopen-2021-058697.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cefazolin	Small molecule	1000 mg	Other
Subject	Gentamicin	Small molecule	80 mg	Other
Subject	Vancomycin	Other / unclassified	1000 mg	Other

Local Antibiotics for Breast Implants

Summary

Timeline

Publications

Drugs

Indications