Local Antibiotics for Breast Implants

Last updated: February 9, 2026
Sponsor: Mikkel Herly
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

Gentamicin, Cefazolin and Vancomycin

Clinical Study ID

NCT04731025
BREAST-AB-01
0058322
2020-002459-40
R-189- A4127
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 disinfectingagents in the breast implant cavity

  • Myasthenia Gravis

Study Design

Total Participants: 1003
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 27, 2021
Estimated Completion Date:
August 31, 2027

Study Description

The BREAST-AB Trial will include women undergoing breast reconstruction with implants. The objective is to determine the efficacy of local antibiotics in decreasing all-cause implant explantation. Participants will be randomized to local application of placebo or gentamicin, vancomycin and cefazolin in a saline solution onto the implant and the dissected breast pocket. All patients undergoing unilateral breast reconstruction will be randomized to the trial drug or placebo in a ratio of 1:1. All patients undergoing bilateral reconstruction will be randomized to the trial treatment on one of their breasts and placebo to the contralateral breast. A total number of 1274 of breasts undergoing breast reconstruction will be included in the trial.

Connect with a study center

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Aalborg University Hospital

    Aalborg 2624886, 9000
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 8000
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus 2624652, 8000
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen 2618425, 2100
    Denmark

    Active - Recruiting

  • South-West Jutland Hospital

    Esbjerg, 6700
    Denmark

    Site Not Available

  • South-West Jutland Hospital

    Esbjerg 2622447, 6700
    Denmark

    Site Not Available

  • Herlev and Gentofte Hospital

    Herlev, 2730
    Denmark

    Site Not Available

  • Herlev and Gentofte Hospital

    Herlev 2620431, 2730
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense, 5000
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense 2615876, 5000
    Denmark

    Active - Recruiting

  • Zealand University Hospital

    Roskilde, 4000
    Denmark

    Site Not Available

  • Zealand University Hospital

    Roskilde 2614481, 4000
    Denmark

    Active - Recruiting

  • Vejle Hospital

    Vejle, 7100
    Denmark

    Site Not Available

  • Vejle Hospital

    Vejle 2610613, 7100
    Denmark

    Site Not Available

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