RECRUITING
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Pulsed Lavage in Implant-Based Breast Reconstruction
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.
Conditions:
🦠 Breast Reconstruction
🗓️ Study Start (Actual) 1 March 2024
🗓️ Primary Completion (Estimated) August 2025
✅ Study Completion (Estimated) August 2025
👥 Enrollment (Estimated) 62
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Female
    • * Between 18 and 75 years of age, inclusive
    • * Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy
    • * Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document

    Exclusion Criteria:

    • * Male
    • * \< 18 years of age or \> 75 years of age
    • * Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 October 2022
  • First Submitted that Met QC Criteria 14 October 2022
  • First Posted 19 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 March 2024
  • Last Update Posted 29 March 2024
  • Last Verified March 2024
I'm interested ...!!