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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350700
• Other study ID #: MW2012-01-02
• Status: Completed
• Phase: N/A
• First received: May 8, 2011
• Last updated: October 31, 2017
• Start date: June 2011
• Est. completion date: November 22, 2011

Study information

• Verified date: May 2011
• Source: MediWound Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: November 22, 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Quality of Life
• Scars Formation

Intervention

Other:
• Scars assessment & QOL
Scar assessment and quality of life questionnaires

Locations

Country	Name	City	State
Slovakia	Clinic of Burns and reconstructive surgery hospital	Kosice

Sponsors (1)

Lead Sponsor	Collaborator
MediWound Ltd

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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