Local Antibiotics for Breast Implants

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMikkel Herly

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Biologically female

Signed informed consent

Immediate or delayed reconstructions

Disqualifiers

Pregnancy

Breast feeding

Known allergy towards Vancomycin, Gentamicin and Cefazolin

Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides

Trial design

Treatments tested in this trial

  • Gentamicin, Cefazolin and Vancomycin
  • Placebo

Treatment groups

1,003 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mikkel Herly

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

University of Copenhagen

Collaborator

Herlev and Gentofte Hospital

Collaborator

Zealand University Hospital

Collaborator

Odense University Hospital

Collaborator

Vejle Hospital

Collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

Collaborator

Aarhus University Hospital

Collaborator

Aalborg University Hospital

Collaborator