Status:
RECRUITING
Local Antibiotics for Breast Implants
Lead Sponsor:
Mikkel Herly
Collaborating Sponsors:
University of Copenhagen
Herlev and Gentofte Hospital
Conditions:
Implant Complication
Implant Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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-caus...
Detailed 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. Par...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 27 2026
Estimated Enrollment :
1003 Patients enrolled
Trial Details
Trial ID
NCT04731025
Start Date
January 27 2021
End Date
January 27 2026
Last Update
May 10 2024
Active Locations (8)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Aarhus University Hospital
Aarhus, Denmark, 8000
3
Rigshospitalet
Copenhagen, Denmark, 2100
4
South-West Jutland Hospital
Esbjerg, Denmark, 6700