Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care (SOC) Protocol MW2012-12-12

Conditions
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Burns, Upper Extremity, Burns, Lower Extremity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults and children who had participated and completed study MW2004-11-02. Patients must be able to sign and dated written informed consent prior to study entry (by Patient or by a guardian, when applicable). Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 61 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Debrase<br>Patients previously treated with Debrase for burn debridement | |
| Standard of Care<br>Patients previously treated with local Standard of Care for burn debridement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Self-report questionnaires designed to measure physical function: the Lower Extremity Functional Scale test for burns in the lower extremities and the QuickDASH outcome measure for burns in the upper extremities. Range of motion measurements of the following injured joints: knee, ankle, shoulder, elbow, wrist palm and fingers, as relevant. | 2-5 years following to acute treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functionality, extremities, ROM, Upper and lower Extremity for burned patients