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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01704950
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Patient with 1 traumatic wound (burns included) or 1 reconstruction wound (oncological wounds included)
* Patients for whom the surgeon has recommended that an INTEGRA® SL matrix be implanted (even if the patient is not taking part in the study) with a Split Thickness Skin Graft in the same operating procedure
* Wound treated with only one layer of a maximum size 10cm\*12.5cm
Exclusion Criteria:
* Immunosuppressed patient
* Chronic wound (with no healing since 6 months)
* Addition of any substances (growth factor, stem cells,…) in the IDRT SL during the surgery
* Patient with a corticoid treatment with a daily dose greater than 5 mg
* Patients whose life expectancy is less than 12 months
* Patients whose mental health or health condition (Visual deficiency, Alzheimers…) would compromise completion of the self-evaluation questionnaires
* Patient with an hypersensitivity to bovine collagen, chondroitin
* Patient with clinical signs of infection (fever, pain, colour, swelling,…) and for whom the investigator diagnosed infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01704950
Study Brief:
Protocol Section:
NCT01704950