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)

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 Overview

• Status: Completed
• Conditions: Quality of Life; Scars Formation
• Intervention / Treatment: Other: Scars assessment & QOL

• Study Type: Observational
• Enrollment (Anticipated): 148

Contacts and Locations

Study Locations

• Slovakia
  • Kosice, Slovakia
    • Clinic of Burns and reconstructive surgery hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that have previously participated in MW2004-011-02 study

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients that were treated in MW2004-011-02 study with Debrase	Other: Scars assessment & QOL; Scar assessment and quality of life questionnaires
Patients that were treated in MW2004-011-02 with SOC	Other: Scars assessment & QOL; Scar assessment and quality of life questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	Approximately 2 years after wound closure

Collaborators and Investigators

• Sponsor: MediWound Ltd
• Investigators: Principal Investigator: Jan Koller, MD,PhD, Department Head of Burs and Reconstructive Surgery

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 22, 2011

Study Registration Dates

• First Submitted: May 8, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: QOL
• Other Study ID Numbers: MW2012-01-02