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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02164760
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
1. with acute burns/trauma wounds that require skin grafting (group 1) OR
2. with scar problems requiring surgical treatment (group 2)
* Full thickness skin defects of 50 cm2 or more, but \<50% TBSA
* Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted
* Informed consent by the patient
Exclusion Criteria:
* Patients with infected wounds
* Pregnant or breast feeding females
* Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer)
* Known allergy against porcine collagen or elastin
* Patients who are expected (according to the responsible medical doctor) to be noncompliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
* Previous enrolment of the patient into the current study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02164760
Study Brief:
Protocol Section:
NCT02164760