Pulsed Lavage in Implant-Based Breast Reconstruction

StatusTerminated
PhaseNot applicable
Started

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Record History

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  1. Trial terminated Sponsor's reason: Changes in personnel Show 4 more changesShow less
    • Final enrollment: 36 participants (planned 62)
    • Primary completion date changed from estimate of Mar 2027 to Jul 1, 2026
    • Site details revised
    • Eligibility criteria expanded, about 1 word
  2. Primary completion date: Mar 2026 to Mar 2027
    • Study completion date: Aug 2026 to Aug 2027
    v11
  3. Primary completion date: Aug 2025 to Mar 2026
    • Study completion date: Aug 2025 to Aug 2026
    • Site contact updated
    v10
  4. Site contact updatedv9
  5. Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: Feb 2025 to Aug 2025
    • Study completion date: Feb 2026 to Aug 2025
    • Start date changed from estimate of Mar 2024 to Mar 1, 2024
    • Site details revised
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Feb 2024 to Mar 2024v7
  2. Start date: Aug 2023 to Feb 2024
    • Primary completion date: Dec 2024 to Feb 2025
    • Study completion date: Dec 2025 to Feb 2026
    v6
  3. Start date: Jun 2023 to Aug 2023
    • Primary completion date: Jun 2024 to Dec 2024
    • Study completion date: Dec 2024 to Dec 2025
    • Site contact updated
    v5
  4. Start date: Mar 2023 to Jun 2023
    • Primary completion date: Jan 2024 to Jun 2024
    • Study completion date: Apr 2024 to Dec 2024
    v4
  5. Primary completion date: Oct 2023 to Jan 2024v3 Show 5 more changesShow less
    • Study completion date: Dec 2023 to Apr 2024
    • Start date: Jan 2023 to Mar 2023
    • Interventions: Acellular dermal matrix (Other), Bilateral or unilateral mastectomy (Procedure), Implant-based breast reconstruction (Procedure), Pulse… to Acellular dermal matrix (Other), Bilateral or unilateral mastectomy (Procedure), Implant-based breast reconstruction (Procedure), Pulsed…
    • Study description revised
    • Study title revised
  6. Start date: Oct 2022 to Jan 2023
    • Interventions: Current Standard of Care (Other), Pulse Lavage Washout (Procedure) to Acellular dermal matrix (Other), Bilateral or unilateral mastectomy (Procedure), Implant-based breast reconstruction (Procedure), Pulse…
    • Eligibility criteria expanded, about 4 words
    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.
To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.
Trial Details
NCT Number NCT05585710
Lead Sponsor University of Alabama at Birmingham
Conditions
(from sponsor)		 Breast Reconstruction
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov