Phase
Condition
N/ATreatment
Conventional wound dressings
DermaClose Continuous External Tissue Expander Device
DermaClose XL Continuous External Tissue Expander Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
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:
On either the upper or lower extremity (including four-compartment legfasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery,OR
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
Connect with a study center
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.