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

Completed

• Conditions: Scars Formation; Quality of Life
• Interventions: Other: Scars assessment & QOL

• Registration Number: NCT01350700
• Lead Sponsor: MediWound Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-05
• Study First Submitted: 2011-05-08
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Study Start: 2011-06
• Primary Completion: 2011-11
• Study Completion: 2011-11-22
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients that were treated in MW2004-011-02 study with Debrase	Scars assessment & QOL	-
Patients that were treated in MW2004-011-02 with SOC	Scars assessment & QOL	-

Primary Outcome Measures

Name	Time	Method
1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS)	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	Approximately 2 years after wound closure	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).

Trial Locations

Locations (1)

Clinic of Burns and reconstructive surgery hospital; 🇸🇰 Kosice, Slovakia