DermaClose DUKE Fasciotomy and Wound Study

Last updated: March 19, 2025
Sponsor: Baxter Healthcare Corporation
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

Conventional wound dressings

DermaClose Continuous External Tissue Expander Device

DermaClose XL Continuous External Tissue Expander Device

Clinical Study ID

NCT05330767
BXU568622
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 legfasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery,OR

  2. Undergoing a four-compartment leg fasciotomy requiring conventional wounddressing.

  • Patient has signed a written informed consent form (ICF) per 21 Code of FederalRegulations (CFR) Part 50.55(e).

Exclusion

Exclusion Criteria:

  • Patient in whom the product was used off-label (except for patients who have thedevice 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.

Study Design

Total Participants: 7
Treatment Group(s): 3
Primary Treatment: Conventional wound dressings
Phase:
Study Start date:
August 22, 2022
Estimated Completion Date:
November 13, 2023

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

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