Long Term Follow up of Scars Formation and Quality of Life Assessment Study

MediWound Ltd148 enrolled

Overview

In previous study (MW2004-011-02), patients with burn wounds had their damaged skin removed by either standard of care treatment or by Debrase Gel Dressing (DGD), which is composed of enzymes that dissolve the damaged skin selectively (DGD removes only the damaged skin and not other parts of the skin). The burn wound, like any other wound, heals by the formation of scar at the injured site in order to replace the destroyed tissues. Scarring is not a static process, but rather a dynamic one, changing over time, especially during the first 24 months post-injury. Scars and patients' quality of life from two treatment arms (DGD and SOC) will be compared in order to evaluate the long term influence of damaged skin removal and wound care techniques on scar formation and maturation.

Study Type

OBSERVATIONAL

Enrollment

148

Conditions

Scars Formation Quality of Life

Interventions

Scars assessment & QOLOTHER

Scar assessment and quality of life questionnaires

Eligibility

Sex: ALLMin age: 4 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion criteria 1. Adults and children who had participated and completed study MW2004-11-02. 2. Subjects must be willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).

Outcomes

Primary Outcomes

1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS)

Assesment of scars will be done using the Modified Vancouver Scar Scale

Time frame: Approximately 2 years after wound closure

2. To evaluate and compare the Quality of Life (QoL) in adult and children that their burn wounds were treated with Debrase or SOC in study MW2004-11-02

2\. A Quality of Life (QoL) assessment will be performed in burn victims using a Short Form 36 (SF-36) and Burn Outcomes Questionnaire (BOQ).