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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01800981
• Other study ID #: MW2012-12-12
• Status: Not yet recruiting
• Phase: N/A
• First received: February 26, 2013
• Last updated: February 27, 2013
• Start date: March 2013

Study information

• Verified date: February 2013
• Source: MediWound Ltd
• Contact: Keren David, MSc
• Phone: +972-8-9324003
• Email: kerend[@]mediwound.co.il
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionGermany: Ethics CommissionSlovak Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 53
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 61 Years

Eligibility

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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Burns, Lower Extremity
• Burns, Upper Extremity

Locations

Country	Name	City	State
Slovakia	Clinic of Burns and reconstructive surgery hospital	Kosice

Sponsors (1)

Lead Sponsor	Collaborator
MediWound Ltd

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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.	2-5 years following to acute treatment	No