Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01350700
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : November 1, 2017
Sponsor:
Information provided by:
MediWound Ltd

Tracking Information
First Submitted Date May 8, 2011
First Posted Date May 10, 2011
Last Update Posted Date November 1, 2017
Study Start Date June 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2011)
  • 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 ]
    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 ]
    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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01350700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Follow up of Scars Formation and Quality of Life Assessment Study
Official Title Scar Formation and Quality of Life Assessment in Subjects (Adults & Children) Following Treatment With Debrase Compared to Standard of Care (SOC)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients that have previously participated in MW2004-011-02 study
Condition
  • Scars Formation
  • Quality of Life
Intervention Other: Scars assessment & QOL
Scar assessment and quality of life questionnaires
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: May 9, 2011)
148
Original Estimated Enrollment Same as current
Actual Study Completion Date November 22, 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01350700
Other Study ID Numbers MW2012-01-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dina Kofler ,Clinical Project Manager, MediWound Ltd, Bio-technology company, MediWound Ltd
Study Sponsor MediWound Ltd
Collaborators Not Provided
Investigators
Principal Investigator: Jan Koller, MD,PhD Department Head of Burs and Reconstructive Surgery
PRS Account MediWound Ltd
Verification Date May 2011