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

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.

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Key information

Conditions

Scars Formation Quality of Life

Age range

4 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic of Burns and reconstructive surgery hospital

Košice, Slovakia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Scars assessment & QOL

Other

Scar assessment and quality of life questionnaires

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)

Time frame: Approximately 2 years after wound closure

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

Time frame: Approximately 2 years after wound closure
- A Quality of Life (QoL) assessment will be performed in burn victims using a Short Form 36 (SF-36) and Burn Outcomes Questionnaire (BOQ).

Sponsors and collaborators

Lead sponsor

MediWound Ltd

Industry

Registry information

Official study title

Scar Formation and Quality of Life Assessment in Subjects (Adults & Children) Following Treatment With Debrase Compared to Standard of Care (SOC)

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 10, 2011
Registry last updated: Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed