Using local antibiotics to prevent complications in breast implants

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)

This study is testing whether using local antibiotics during breast implant surgery can help prevent complications and the need to remove the implants in women getting breast reconstruction.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 1003 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Rigshospitalet, Denmark (other)
• Locations: 8 sites (Aalborg and 7 other locations)
• Trial ID: NCT04731025 on ClinicalTrials.gov

What this trial studies

The BREAST-AB Trial is a multi-center, randomized, double-blind, placebo-controlled trial aimed at evaluating the effectiveness of local antibiotics, specifically gentamicin, vancomycin, and cefazolin, in reducing the need for implant explantation after breast reconstruction. Women undergoing breast reconstruction with implants will be randomly assigned to receive either the antibiotic treatment or a placebo applied directly to the implant and the surrounding tissue. The trial will include a total of 1274 breasts, with participants undergoing either unilateral or bilateral reconstruction. This approach seeks to address complications such as infections and capsular contracture that can arise post-surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are biologically female patients aged 18 and older who are scheduled for breast reconstruction with implants or expanders.

Not a fit: Patients who are pregnant, breastfeeding, or have known allergies to the study antibiotics will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the rate of implant-related complications and the need for additional surgeries in breast reconstruction patients.

How similar studies have performed: Other studies have shown promise in using local antibiotics for preventing infections in surgical settings, suggesting that this approach may be effective.

Eligibility criteria

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 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

Where this trial is running

Aalborg and 7 other locations

• Aalborg University Hospital — Aalborg, Denmark (RECRUITING)
• Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
• Rigshospitalet — Copenhagen, Denmark (RECRUITING)
• South-West Jutland Hospital — Esbjerg, Denmark (NOT_YET_RECRUITING)
• Herlev and Gentofte Hospital — Herlev, Denmark (RECRUITING)
• Odense University Hospital — Odense, Denmark (RECRUITING)
• Zealand University Hospital — Roskilde, Denmark (RECRUITING)
• Vejle Hospital — Vejle, Denmark (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Mikkel Herly, MD, Ph.D. — Department of Plastic Surgery and Burns Treatment
• Study coordinator: Mikkel Herly, MD, Ph.D.

Conditions: Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion, Antibiotic Side Effect