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
  Purpose

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.


Condition Intervention
Scars Formation
Quality of Life
Other: Scars assessment & QOL

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Scar Formation and Quality of Life Assessment in Subjects (Adults & Children) Following Treatment With Debrase Compared to Standard of Care (SOC)

Resource links provided by NLM:


Further study details as provided by MediWound Ltd:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 148
Study Start Date: June 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350700

Contacts
Contact: Dina Kofler, BSc, MBA +972-8-9324012 dinak@mediwound.co.il

Locations
Slovakia
Clinic of Burns and reconstructive surgery hospital Not yet recruiting
Kosice, Slovakia
Principal Investigator: Jan Koller, MD, PhD         
Sponsors and Collaborators
MediWound Ltd
Investigators
Principal Investigator: Jan Koller, MD,PhD Department Head of Burs and Reconstructive Surgery
  More Information

No publications provided

Responsible Party: Dina Kofler ,Clinical Project Manager, MediWound Ltd, Bio-technology company, MediWound Ltd
ClinicalTrials.gov Identifier: NCT01350700     History of Changes
Other Study ID Numbers: MW2012-01-02
Study First Received: May 8, 2011
Last Updated: May 9, 2011
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee
Romania: National Authority for Scientific Research
Romania: State Institute for Drug Control
Israel: Ethics Commission
Australia: Human Research Ethics Committee
India: Institutional Review Board
Germany: Ethics Commission
Poland: Ethics Committee
Poland: Ministry of Health
Slovak Republic: Ethics Committee
France: National Consultative Ethics Committee for Health and Life Sciences
Brazil: National Committee of Ethics in Research

Keywords provided by MediWound Ltd:
QOL

ClinicalTrials.gov processed this record on September 22, 2014