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Local Antibiotics for Women Undergoing Breast Reconstruction Surgery with Implants
EU CTIS ID: 2024-517672-38-00
What this study is testing
The BREAST-AB trial is designed to assess the effect of locally applied antibiotics on all-cause loss of the implant after implant-based breast reconstruction. We hypothesise that local application of gentamicin, vancomycin and cefazolin decrease the risk of postoperative clinical infections and thereby reduce the risk of losing the implant to the benefit of women undergoing implant-based breast reconstruction.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Biologically female
- Signed informed consent
- Scheduled for breast reconstruction with implants or expanders including: a. Immediate or delayed reconstructions b. Bilateral or unilateral reconstructions c. With or without simultaneous flap reconstruction
You likely can't join if
- 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
See the full eligibility criteria
- Age ≥ 18 years
- Biologically female
- Signed informed consent
- Scheduled for breast reconstruction with implants or expanders including: a. Immediate or delayed reconstructions b. Bilateral or unilateral reconstructions c. With or without simultaneous flap reconstruction
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.