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

• Conditions: Burns, Upper Extremity; Burns, Lower Extremity

• Registration Number: NCT01800981
• Lead Sponsor: MediWound Ltd

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 Timeline

• Status Verified: 2013-02
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-27
• Last Update Submitted: 2013-02-27
• Study First Posted: 2013-02-28
• Last Update Posted: 2013-02-28
• Study Start: 2013-03
• Primary Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functionality evaluation using self reported questionnaires and ROM measurements	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.

Trial Locations

Locations (1)

Clinic of Burns and reconstructive surgery hospital; 🇸🇰 Kosice, Slovakia