Local Antibiotics for Breast Implants
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion, Antibiotic Side Effect
In brief
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.
Key facts
- Study ID
- NCT04731025
- Run by
- Mikkel Herly
- People needed
- 1003
- Starts
- 2021-01-27
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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 may not qualify if…
- 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
Where it is running
- Aalborg University Hospital — Aalborg, Denmark (enrolling)
- Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Odense University Hospital — Odense, Denmark (enrolling)
- Zealand University Hospital — Roskilde, Denmark (enrolling)
- Herlev and Gentofte Hospital — Herlev, Denmark (enrolling)
- South-West Jutland Hospital — Esbjerg, Denmark
- Vejle Hospital — Vejle, Denmark
Full record on ClinicalTrials.gov
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