Status:
TERMINATED
DermaClose DUKE Fasciotomy and Wound Study
Lead Sponsor:
Baxter Healthcare Corporation
Collaborating Sponsors:
Duke University
Conditions:
Wound of Skin
Eligibility:
All Genders
18+ years
Brief 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 o...
Eligibility Criteria
Inclusion
- Patient is at least 18 years of age at the time of consent.
- Patient with a full thickness acute wound(s) of the skin:
- On either the upper or lower extremity (including four-compartment leg fasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery, OR
- 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
- 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.
Key Trial Info
Start Date :
August 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 13 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05330767
Start Date
August 22 2022
End Date
November 13 2023
Last Update
March 21 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710