Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT05330767
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05330767
Study Brief:
Protocol Section:
NCT05330767