Local Antibiotics for Breast Implants

• Status: Recruiting
• Trial end date: 2024-07-27
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mikkel Herly
• Collaborators: Herlev and Gentofte Hospital; Odense University Hospital; Sydvestjysk Hospital; University of Copenhagen; Vejle Hospital; Zealand University Hospital
• Treatments: Cefazolin; Gentamicins; Vancomycin

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Biologically female

• Signed informed consent

• Scheduled for breast reconstruction with implants or expanders including:

1. Immediate or delayed reconstructions

2. Bilateral or unilateral reconstructions

3. With or without simultaneous flap reconstruction

Exclusion Criteria:

• 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