Local Antibiotics for Breast Implants (BREAST-AB)

  • STATUS
    Recruiting
  • End date
    Jul 27, 2025
  • participants needed
    1003
  • sponsor
    Mikkel Herly
Updated on 9 July 2022
Accepts healthy volunteers

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.

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.

Details
Condition Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion, Antibiotic Side Effect
Treatment Placebo, Gentamicin, Cefazolin and Vancomycin
Clinical Study IdentifierNCT04731025
SponsorMikkel Herly
Last Modified on9 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Biologically female
Signed informed consent
Scheduled for breast reconstruction with implants or expanders including
Immediate or delayed reconstructions
Bilateral or unilateral reconstructions
With or without simultaneous flap reconstruction

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 disinfecting agents in the breast implant cavity
Myasthenia Gravis
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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