Actively Recruiting
Local Antibiotics for Breast Implants
Led by Mikkel Herly · Updated on 2026-02-12
1003
Participants Needed
8
Research Sites
339 weeks
Total Duration
On this page
Sponsors
M
Mikkel Herly
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Local Antibiotics for Breast Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years
- Biologically female
- Signed informed consent
- Scheduled for breast reconstruction with implants or expanders including:
- Immediate or delayed reconstructions
- Bilateral or unilateral reconstructions
- With or without simultaneous flap reconstruction
You will not qualify if you...
- Pregnancy
- Breast feeding
- Known allergy towards Vancomycin, Gentamicin and Cefazolin
- Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
- Known allergy towards neomycin
- Known impaired renal function with GFR < 60 mL/min
- Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
- Myasthenia Gravis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
2
Aarhus University Hospital
Aarhus, Denmark, 8000
Actively Recruiting
3
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
South-West Jutland Hospital
Esbjerg, Denmark, 6700
Not Yet Recruiting
5
Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
6
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
7
Zealand University Hospital
Roskilde, Denmark, 4000
Actively Recruiting
8
Vejle Hospital
Vejle, Denmark, 7100
Not Yet Recruiting
Research Team
M
Mikkel Herly, MD, Ph.D.
CONTACT
M
Mathilde Hemmingsen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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