Local Antibiotics for Breast Implants
Recruiting
Phase 3
Interventional Study
Implant Complication
Implant Infection
Implant Site Infection
Implant Capsular Contracture
Implant Site Pocket Infection
Implant Expulsion
Antibiotic Side Effect
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,003 (estimated)
- Sponsor
- Mikkel Herly · Other
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Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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.
Trial Locations
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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 reconstruct…
Contacts