drugset / Trial / NCT04731025
Local Antibiotics for Breast Implants
Phase 3
Recruiting
1003 enrolled
Mikkel Herly
Aalborg University Hospital · collabAarhus University Hospital · collabEsbjerg Hospital - University Hospital of Southern Denmark · collabHerlev and Gentofte Hospital · collabOdense University Hospital · collabUniversity of Copenhagen · collabVejle Hospital · collabZealand University Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2021-01-27
- Primary completion
- 2027-02
- Completion
- 2027-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cefazolin | Small molecule | 1000 mg | — |
| Subject | Gentamicin | Small molecule | 80 mg | — |
| Subject | Vancomycin | Other / unclassified | 1000 mg | — |