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Recruiting NCT04731025

Local Antibiotics for Breast Implants

Phase III Interventional Implant Complication Implant Infection Implant Site Infection Implant Capsular Contracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gentamicin, Cefazolin and Vancomycin, Placebo.
Who it may be relevant to
Registry conditions: Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial (The BREAST-AB Trial)

Overview

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.

Detailed 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.

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.

Primary outcome measures

  • All-cause explantation of the breast implant after the breast reconstruction surgery [Time frame: 180 days]
Secondary outcome measures (5)
  • Time to explantation (days) [Time frame: 180 days]
  • Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N) [Time frame: 180 days]
  • Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N) [Time frame: 180 days]
  • Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery [Time frame: 180 days]
  • All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Denmark · 8 centers
  • Aalborg University Hospital — Aalborg
  • Aarhus University Hospital — Aarhus
  • Rigshospitalet — Copenhagen
  • South-West Jutland Hospital — Esbjerg
  • Herlev and Gentofte Hospital — Herlev
  • Odense University Hospital — Odense
  • Zealand University Hospital — Roskilde
  • Vejle Hospital — Vejle

Publications

  • Hemmingsen MN, Larsen A, Weltz TK, Orholt M, Wiberg S, Bennedsen AK, Bille C, Carstensen LF, Jensen LT, Bredgaard R, Koudahl V, Schmidt VJ, Vester-Glowinski P, Holmich LR, Sorensen SJ, Bjarnsholt T, Damsgaard T, Herly M. Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: protocol for a ra PMID 36115667

Identifiers

NCT: NCT04731025 · BREAST-AB-01 · 2020-002459-40 · 0058322 · R-189- A4127

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗