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Local Antibiotics for Breast Implants
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.
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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1003
Start Date
2021-01-27
Completion Date
2027-08
Last Updated
2026-02-12
Healthy Volunteers
Yes
Conditions
Interventions
Gentamicin, Cefazolin and Vancomycin
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
Placebo
500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
Locations (8)
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
South-West Jutland Hospital
Esbjerg, Denmark
Herlev and Gentofte Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark
Zealand University Hospital
Roskilde, Denmark
Vejle Hospital
Vejle, Denmark