An observational study in Burns, Upper Extremity and Burns, Lower Extremity, sponsored by MediWound Ltd. Status unknown at 1 site in Slovakia. Open to participants aged 10 Years to 61 Years. Per ClinicalTrials.gov, last updated 2013-02-28.
Sponsored by MediWound Ltd · Observational
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).
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's planned enrollment of 53 is close to the median of 55 across 135 observational studies indexed under Burns.
Browse Burns studies →MediWound Ltd is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients previously treated with Debrase for burn debridement
Patients previously treated with local Standard of Care for burn debridement
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: 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.
Time frame: 2-5 years following to acute treatment
This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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