NCT01350700

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 148 (estimated)
• Sponsor: MediWound Ltd · Industry
• Sex: All
• Age: 4 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Scars Formation
• Quality of Life

Interventions

Type	Name	Description
OTHER	Scars assessment & QOL	Scar assessment and quality of life questionnaires

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-11-01
• Completion: 2011-11-22
• First posted: 2011-05-10
• Last updated: 2017-11-01

Locations

1 site across 1 country: Slovakia