DermaClose DUKE Fasciotomy and Wound Study
To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy.
Conditions:
🦠 Wound of Skin
🗓️ Study Start (Actual) 22 August 2022
🗓️ Primary Completion (Estimated) 23 October 2023
✅ Study Completion (Estimated) 23 October 2023
👥 Enrollment (Estimated) 70
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patient is at least 18 years of age at the time of consent.
    • * Patient with a full thickness acute wound(s) of the skin:
    • 1. On either the upper or lower extremity (including four-compartment leg fasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery, OR
    • 2. Undergoing a four-compartment leg fasciotomy requiring conventional wound dressing.
    • * Patient has signed a written informed consent form (ICF) per 21 Code of Federal Regulations (CFR) Part 50.55(e).

    Exclusion Criteria:

    • * Patient in whom the product was used off-label (except for patients who have the device on for longer than 14 days)
    • * Patient with wound(s) that exhibit any of the following:
    • * Ischemic tissue,
    • * Infected tissue,
    • * Acute burned tissue,
    • * Fragile tissue at the edges of the wound(s).
    • * Patient, who in surgeon's opinion, does not fit the criteria for this study.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
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 8 April 2022
  • First Submitted that Met QC Criteria 8 April 2022
  • First Posted 15 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 February 2023
  • Last Update Posted 21 February 2023
  • Last Verified February 2023