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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT04026334
Eligibility Criteria:
Inclusion Criteria:
1. is anticipated to be hospitalized for the duration of treatment.
2. is ≥22 years of age or their legally authorized representative is able to provide informed consent.
3. has a full thickness wound (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) measuring ≥4cm in length and ≥4cm in width (before removal of eschar at the bedside) excluding undermining/tunneling.
4. has, in the opinion of the investigator, no more than 2/3 of the visible wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
5. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).
Exclusion Criteria:
1. has been diagnosed with malignancy in the wound.
2. has untreated osteomyelitis.
3. has an untreated systemic infection.
4. has active cellulitis in the peri wound area.
5. has a known allergy or hypersensitivity to study materials: dressing and/or dressing components such as acrylic adhesives or polyurethane.
6. has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
7. has had radiation directly to the wound.
8. has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
9. has eschar in the wound that cannot be removed by beside or sharp and/or mechanical debridement.
10. is participating in another interventional clinical trial for the duration of the study.
11. has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
12. has inadequate hemostasis at the wound site, as determined by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT04026334
Study Brief:
Protocol Section:
NCT04026334