Burns, Lower Extremity Clinical Trial
Official title:
Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care (SOC) Protocol MW2012-12-12
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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Time Perspective: Prospective