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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01350700

Enrollment

148

Registered

2011-05-10

Start date

2011-06-30

Completion date

2011-11-22

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Scars Formation

Keywords

QOL

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.

Interventions

OTHERScars assessment & QOL

Scar assessment and quality of life questionnaires

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

4 Years to 55 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026