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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by MediWound Ltd
Sponsor:
Information provided by (Responsible Party):
MediWound Ltd
ClinicalTrials.gov Identifier:
NCT01800981
First received: February 26, 2013
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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
Burns, Upper Extremity
Burns, Lower Extremity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care (SOC) Protocol MW2012-12-12

Resource links provided by NLM:


Further study details as provided by MediWound Ltd:

Primary Outcome Measures:
  • Functionality evaluation using self reported questionnaires and ROM measurements [ Time Frame: 2-5 years following to acute treatment ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 53
Study Start Date: March 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Debrase
Patients previously treated with Debrase for burn debridement
Standard of Care
Patients previously treated with local Standard of Care for burn debridement

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).

  Eligibility

Ages Eligible for Study:   10 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800981

Contacts
Contact: Keren David, MSc +972-8-9324003 kerend@mediwound.co.il
Contact: Efrat Hazan, BSc +972-8-9324051 efrath@mediwound.co.il

Locations
Slovakia
Clinic of Burns and reconstructive surgery hospital
Kosice, Slovakia
Sponsors and Collaborators
MediWound Ltd
Investigators
Principal Investigator: Jan Koller, PhD Department Head of Burs and Reconstructive Surgery
  More Information

No publications provided

Responsible Party: MediWound Ltd
ClinicalTrials.gov Identifier: NCT01800981     History of Changes
Other Study ID Numbers: MW2012-12-12
Study First Received: February 26, 2013
Last Updated: February 27, 2013
Health Authority: Israel: Ethics Commission
Germany: Ethics Commission
Slovak Republic: Ethics Committee

Keywords provided by MediWound Ltd:
Functionality
extremities
ROM
Upper and lower Extremity for burned patients

ClinicalTrials.gov processed this record on September 30, 2014