Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care
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|ClinicalTrials.gov Identifier: NCT01800981|
Recruitment Status : Unknown
Verified February 2013 by MediWound Ltd.
Recruitment status was: Not yet recruiting
First Posted : February 28, 2013
Last Update Posted : February 28, 2013
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
|Condition or disease|
|Burns, Upper Extremity Burns, Lower Extremity|
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 Type :||Observational|
|Estimated Enrollment :||53 participants|
|Official Title:||Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care (SOC) Protocol MW2012-12-12|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||July 2013|
Patients previously treated with Debrase for burn debridement
Standard of Care
Patients previously treated with local Standard of Care for burn debridement
- 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:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800981
|Contact: Keren David, MScfirstname.lastname@example.org|
|Contact: Efrat Hazan, BScemail@example.com|
|Clinic of Burns and reconstructive surgery hospital|
|Principal Investigator:||Jan Koller, PhD||Department Head of Burs and Reconstructive Surgery|