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Once the victim survived the acute phase, the outcome of wound healing, the scarring, became a major medical issue with complications that may lead to cosmetic and functional sequelae. Scar tissue is clinically distinguished from normal skin by an aberrant color, rough surface texture, increased thickness (hypertrophy), contraction, firmness and sometimes, decrease function.
Thus, functional and cosmetic outcomes became at least important as wound closure in assessing wound healing products
This is a multi-center, assessor-blinded study aiming to evaluate the long term functionality in adults and children who have participated in study MW2004-11-02 (previous phase 3 study).
We had previously shown that by using the MVSS scale which includes objective assessment of the physical characteristics of size, shape, volume, color, texture, and pliability as well as structural, mechanical and physiologic characteristics, lower (favorable) scores in Debrase vs. SOC group were observed in sub-groups of highly functional body parts of the hands and feet. This study will include specific functionality evaluation using the "Lower Extremity Functional Scale" test for burns in the lower extremities and the "QuickDASH" outcome measure for burns in the upper extremities as well as range of motion measurements of the joints (knee, ankle, shoulder, elbow and wrist, as relevant).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Debrase | Patients previously treated with Debrase for burn debridement | ||
| Standard of Care | Patients previously treated with local Standard of Care for burn debridement |
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| Measure | Description | Time Frame |
|---|---|---|
| Functionality evaluation using self reported questionnaires and ROM measurements | Functionality evaluation of wounds that have been treated by Debrase or SOC during the previous phase 3 study by:
| 2-5 years following to acute treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Adults and children who had participated and completed study MW2004-11-02 (previous phase 3 study) will be contacted. Patients who will agree to participate in the study will be invited to the clinic for a one day visit for assessments.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keren David, MSc | Contact | +972-8-9324003 | kerend@mediwound.co.il | |
| Efrat Hazan, BSc | Contact | +972-8-9324051 | efrath@mediwound.co.il |
| Name | Affiliation | Role |
|---|---|---|
| Jan Koller, PhD | Department Head of Burs and Reconstructive Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Burns and reconstructive surgery hospital | Košice | Slovakia |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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