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

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 53

Contacts and Locations

• Study Contact: Name: Keren David, MSc; Phone Number: +972-8-9324003; Email: kerend@mediwound.co.il
• Study Contact Backup: Name: Efrat Hazan, BSc; Phone Number: +972-8-9324051; Email: efrath@mediwound.co.il

Study Locations

• Slovakia
  • Kosice, Slovakia
    • Clinic of Burns and reconstructive surgery hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 61 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Debrase; Patients previously treated with Debrase for burn debridement
Standard of Care; Patients previously treated with local Standard of Care for burn debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MediWound Ltd
• Investigators: Principal Investigator: Jan Koller, PhD, Department Head of Burs and Reconstructive Surgery

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Estimate): February 28, 2013
• Last Update Submitted That Met QC Criteria: February 27, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Functionality; ROM; extremities; Upper and lower Extremity for burned patients
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: MW2012-12-12