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

NCT01350700 | Completed

• 1 other identifier: MW2012-01-02
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Scars Formation; Quality of Life

Keywords

QOL

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Other: Scars assessment & QOL

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

Other: Scars assessment & QOL

Interventions

Scars assessment & QOL OTHER

Scar assessment and quality of life questionnaires

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

Eligibility Criteria

• Age: 4 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adults and children who had participated and completed study MW2004-11-02.
• Subjects must be willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).

Sponsors & Collaborators

• MediWound Ltd: lead

Study Sites (1)

Clinic of Burns and reconstructive surgery hospital

Košice, Slovakia

Location

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jan Koller, MD,PhD

  Department Head of Burs and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2011
• First Posted: May 10, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 22, 2011
• Last Updated: November 1, 2017

Record last verified: 2011-05

Locations

SL (1)