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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT03334656
Eligibility Criteria:
Inclusion Criteria:
* Female or male aged ≥18 years old
* For potentially childbearing female, only those with effective contraception (contraception pill, implant and intrauterine device) could be included
* Patient who need skin graft ( height equal to or greater than 100cm2 and thickness 1.2mm) after surgery excision
* Patients with social security
* Patients able to understand and follow the trial instructions
* Patients who have signed an informed consent
Exclusion Criteria:
* Patients with an history of cancers except basal and squamous cell, cutaneous carcinoma.
* Patients suffering from uncontrolled metabolic disease (for instance diabete), from a psychiatric disorder not treated, with severe arteritis of lower and/or upper limbs, treated with anticoagulant (unless treatment stops 7 days before the surgery), with severe venous insufficiency, suffering of severe polyneuropathy, with known allergy to antibiotics,
* Patients with an allergic predisposition or known allergy to bovine collagen or silicone
* Patients receiving corticosteroids, immunosuppressive or cytotoxic agents unless treatment stops 4 weeks before the surgery
* Patients contraindicated with local anesthetic used in STSG process of his investigator center
* Patients with systemic infection (all grade defined by CTCAE Common Terminology Criteria for Adverse Event V4.03) at surgery visit will not be included in this trial because of the contraindication of the surgical gesture.
* Patient intolerant to the conventional treatment (JELONET®)
* Patient intolerant to URGO TUL®
* Patient intolerant to TELFA®
* Patient intolerant to the stretchable strip (HYPAFIX® or NYLEX®)
* Pregnant or breast-feeding women
* Patients participating in clinical trial
* Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03334656
Study Brief:
Protocol Section:
NCT03334656