Local Antibiotics for Breast Implants

Launched by MIKKEL HERLY · Jan 26, 2021

Keywords

ClinConnect Summary

The BREAST-AB Trial is a research study looking at whether applying certain antibiotics directly to breast implants can help prevent complications after breast reconstruction surgery. The antibiotics being tested are gentamicin, vancomycin, and cefazolin. Researchers want to see if using these local treatments can reduce the need to remove implants due to infections or other issues.

To participate in this study, women aged 18 and older who are planning to have breast reconstruction with implants may be eligible. This includes those having surgery right away after a mastectomy or those who have had their surgery delayed. However, certain individuals, such as those who are pregnant, breastfeeding, or have specific allergies and health conditions, cannot participate. If you join the trial, you will receive either the antibiotic treatment or a placebo (a treatment that looks the same but has no active ingredients) without knowing which one you have, to ensure a fair comparison. This study is currently recruiting participants, and it aims to provide valuable information on improving outcomes for women undergoing breast reconstruction.

Gender

FEMALE

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