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

NCT01800981 | Unknown

• 1 other identifier: MW2012-12-12
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Burns, Upper Extremity; Burns, Lower Extremity

Keywords

Functionality; extremities; ROM; Upper and lower Extremity for burned patients

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  2-5 years following to acute treatment

Study Arms (2)

Debrase

Patients previously treated with Debrase for burn debridement

Standard of Care

Patients previously treated with local Standard of Care for burn debridement

Eligibility Criteria

• Age: 10 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• MediWound Ltd: lead

Study Sites (1)

Clinic of Burns and reconstructive surgery hospital

Košice, Slovakia

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jan Koller, PhD

  Department Head of Burs and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keren David, MSc

CONTACT

+972-8-9324003; kerend@mediwound.co.il

Efrat Hazan, BSc

CONTACT

+972-8-9324051; efrath@mediwound.co.il

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

SL (1)