Local Antibiotics for Breast Implants

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.

Conditions

• Implant Complication
• Implant Infection
• Implant Site Infection
• Implant Capsular Contracture
• Implant Site Pocket Infection
• Implant Expulsion
• Antibiotic Side Effect

Interventions

DRUG

Gentamicin, Cefazolin and Vancomycin

The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.

OTHER

Placebo

500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Herlev and Gentofte Hospital

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Vejle Hospital

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Mikkel Herly

  lead OTHER

Principal Investigators

• Mikkel Herly, MD, Ph.D. · Department of Plastic Surgery and Burns Treatment

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-27

Primary Completion

2027-02-28

Completion

2027-08-31

Countries

• Denmark

Study Locations