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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by MediWound Ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
MediWound Ltd
ClinicalTrials.gov Identifier:
NCT01350700
First received: May 8, 2011
Last updated: May 9, 2011
Last verified: May 2011

May 8, 2011
May 9, 2011
June 2011
December 2011   (final data collection date for primary outcome measure)
  • 1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS) [ Time Frame: Approximately 2 years after wound closure ] [ Designated as safety issue: No ]
    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 [ Time Frame: Approximately 2 years after wound closure ] [ Designated as safety issue: No ]
    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).
Same as current
Complete list of historical versions of study NCT01350700 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Observational
Observational Model: Cohort
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Non-Probability Sample

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

  • Scars Formation
  • Quality of Life
Other: Scars assessment & QOL
Scar assessment and quality of life questionnaires
  • Patients that were treated in MW2004-011-02 study with Debrase
    Intervention: Other: Scars assessment & QOL
  • Patients that were treated in MW2004-011-02 with SOC
    Intervention: Other: Scars assessment & QOL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
148
January 2012
December 2011   (final data collection date for primary outcome measure)

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).
Both
4 Years to 55 Years
No
Contact: Dina Kofler, BSc, MBA +972-8-9324012 dinak@mediwound.co.il
Slovakia
 
NCT01350700
MW2012-01-02
No
Dina Kofler ,Clinical Project Manager, MediWound Ltd, Bio-technology company, MediWound Ltd
MediWound Ltd
Not Provided
Principal Investigator: Jan Koller, MD,PhD Department Head of Burs and Reconstructive Surgery
MediWound Ltd
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP