NCT04731025 Local Antibiotics for Breast Implants
| NCT ID | NCT04731025 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mikkel Herly |
| Condition | Implant Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,003 participants |
| Start Date | 2021-01-27 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,003 participants in total. It began in 2021-01-27 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Mikkel Herly, MD, Ph.D.
PRINCIPAL INVESTIGATOR
Department of Plastic Surgery and Burns Treatment
Frequently Asked Questions
Who can join the NCT04731025 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Implant Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04731025 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,003 participants.
Is NCT04731025 currently recruiting?
Yes, NCT04731025 is actively recruiting participants. Contact the research team at mikkel.herly@regionh.dk for enrollment information.
Where is the NCT04731025 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Esbjerg, Denmark and 4 additional locations.
Who is sponsoring the NCT04731025 clinical trial?
NCT04731025 is sponsored by Mikkel Herly. The principal investigator is Mikkel Herly, MD, Ph.D. at Department of Plastic Surgery and Burns Treatment. The trial plans to enroll 1,003 participants.