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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT04030832
Eligibility Criteria:
Inclusion Criteria:
* Full-thickness skin loss from a minimum size of 3x3 cm (9cm2) to a maximum size of 5x5 cm (25cm2);
* Loss of substance caused by abrasive-contusive traumas (loss of full-thickness skin substance) or by thermal burn (deep degree II), present for at least 15 days;
* Absence of clinical signs of infection assessed by two culture swabs performed at T0 (pre and post debridement);
* Pre-operative inflammatory index (VES, PCR) and b-hcg negative;
* Absence of exposure of osteo-cartilaginous structures, of noble structures (major arterial vessels, major nerve trunks, tendons without paratenon);
* Specific written informed consent
Exclusion Criteria:
* Smoking patients (≥ 10 cigarettes / day);
* Patients with type I or type II diabetes mellitus:
* Patients suffering vascular trophic ulcers;
* Patients with loss of substance at the level of the fingers and toes;
* Patients with loss of substance of the foot and the yarrow region;
* Patients with oncological pathologies in progress or in remission;
* Patients in therapy with immunosuppressive and corticosteroid drugs, anticoagulants, antiplatelet agents;
* Patients with autoimmune diseases including connectivitis;
* Patients with congenital, acquired and metabolic immunodeficiencies;
* Pregnant patients (ascertained with β-HCG) and breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04030832
Study Brief:
Protocol Section:
NCT04030832