Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care (SOC) Protocol MW2012-12-12
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- MediWound Ltd
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Functionality evaluation using self reported questionnaires and ROM measurements
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 61 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults and children who had participated and completed study MW2004-11-
- •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
- Not provided
Outcomes
Primary Outcomes
Functionality evaluation using self reported questionnaires and ROM measurements
Time Frame: 2-5 years following to acute treatment
Functionality evaluation of wounds that have been treated by Debrase or SOC during the previous phase 3 study by: 1. 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. 2. Range of motion measurements of the following injured joints: knee, ankle, shoulder, elbow, wrist palm and fingers, as relevant.
Secondary Outcomes
No secondary outcomes reported