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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT04951934
Eligibility Criteria:
Inclusion Criteria:
* Subjects suffering from deep burns who have been surgically treated with autologous skin graft, whose failure has been total or partial;
* The surface of the non-taken skin graft must be between 0.5% and 5.0% of the body surface;
* Men and women aged ≥ 18 years;
* The patient must be able to understand the purpose of the Clinical Study and provide their Informed Consent in writing.
Exclusion Criteria:
* Patients who are participating in other clinical trials with drug or medical device;
* Patients who are unable to understand the aims and the objectives of the study;
* Patients with burns with TBSA greater than 50%;
* Patients with a history of self-harm who can voluntarily alter the course of healing;
* Patients with psychiatric disorders;
* Women who are pregnant or breastfeeding (the state of pregnancy or breastfeeding will be certified on the basis of the patient's declaration);
* Patients with cancer;
* Patients with pathologies that induce photosensitization of the skin;
* Patients with limited life expectancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04951934
Study Brief:
Protocol Section:
NCT04951934