Local Antibiotics for Breast Implants
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.
| Condition(s) | Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion, Antibiotic Side Effect |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Mikkel Herly |
| Locations | Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Esbjerg, Denmark; Herlev, Denmark; Odense, Denmark (+2 more sites) |
| Start date | 2021-01-27 |
| NCT ID | NCT04731025 |
| Official listing | https://clinicaltrials.gov/study/NCT04731025 |