Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
Healthy Volunteers
NCT04731025

Local Antibiotics for Breast Implants

Led by Mikkel Herly · Updated on 2026-02-12

1003

Participants Needed

8

Research Sites

339 weeks

Total Duration

On this page

Sponsors

M

Mikkel Herly

Lead Sponsor

U

University of Copenhagen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Local Antibiotics for Breast Implants

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Aalborg University Hospital

Aalborg, Denmark, 9000

Actively Recruiting

2

Aarhus University Hospital

Aarhus, Denmark, 8000

Actively Recruiting

3

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

4

South-West Jutland Hospital

Esbjerg, Denmark, 6700

Not Yet Recruiting

5

Herlev and Gentofte Hospital

Herlev, Denmark, 2730

Actively Recruiting

6

Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

7

Zealand University Hospital

Roskilde, Denmark, 4000

Actively Recruiting

8

Vejle Hospital

Vejle, Denmark, 7100

Not Yet Recruiting

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Research Team

M

Mikkel Herly, MD, Ph.D.

CONTACT

M

Mathilde Hemmingsen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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