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:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT03624192
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
2. The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
3. Two discrete donor sites of similar size (± 25%) can be created in a similar non-articulating location (excluding the scalp) with each donor site representing a minimum of 1% TBSA.
4. The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.
5. In the opinion of the Investigator, the patient and/or parent/guardian must be able to:
1. Understand the full nature and purpose of the study, including possible risks and adverse events, and
2. Provide informed consent/assent as appropriate for study participation.
6. The patient and/or parent/guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures.
7. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
9. Life expectancy greater than 52 weeks.
Exclusion Criteria:
1. Prior autograft harvest at planned study donor sites.
2. Patients with sepsis or hemodynamic instability.
3. The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.
4. Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.
5. The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.
6. Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation.
7. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
8. Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
16 Years
Study:
NCT03624192
Study Brief:
Protocol Section:
NCT03624192