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

MediWound

Status: Completed

Conditions: Quality of Life; Scars Formation

Treatments: Other: Scars assessment & QOL

Study type: Observational

Funder types: Industry

Identifiers

NCT01350700

MW2012-01-02

Details and patient eligibility

About

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.

Enrollment: 148 estimated patients

Sex: All

Ages: 4 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

148 participants in 2 patient groups

Patients that were treated in MW2004-011-02 study with Debrase

Treatment:

Other: Scars assessment & QOL

Patients that were treated in MW2004-011-02 with SOC

Treatment:

Other: Scars assessment & QOL