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Local Antibiotics for Breast Implants

Study acronym: BREAST-AB
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Publications: details revised at 1 of 1 entry
  2. Enrollment closed, study ongoing
    • Primary completion moved earlier from Feb 2027 to Sep 26, 2026
    • Study completion pushed from Aug 2027 to Sep 2027
    • Site details revised at 8 of 8 sites
    v9
  3. Re-verified, no change to tracked fieldsv8
  4. Primary completion date: Jul 27, 2025 to Feb 2027
    • Study completion date: Jan 27, 2026 to Aug 2027
    v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 6 to 8
    • Study completion date: Jul 27, 2025 to Jan 27, 2026
    • Collaborators: 6 to 8
    v5
  2. Primary and study completion dates: Jul 27, 2024 to Jul 27, 2025
    • Secondary endpoints: 4 to 5
    • Site details revised at 1 of 6 sites
    v4
  3. Site details revised at 1 of 6 sitesv3
  4. Secondary endpoints revised (4)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04731025
Lead Sponsor Mikkel Herly
Collaborators: University of Copenhagen, Herlev and Gentofte Hospital, Zealand University Hospital, Odense University Hospital, Vejle Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Aarhus University Hospital, Aalborg University Hospital
Conditions
(from sponsor)		 Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion, Antibiotic Side Effect
Related terms Implant Capsular Contracture
Enrollment 1,003 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov