Long Term Follow up of Scars Formation and Quality of Life Assessment Study
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ClinicalTrials.gov Identifier: NCT01350700 |
Recruitment Status :
Completed
First Posted : May 10, 2011
Last Update Posted : November 1, 2017
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Tracking Information | ||||
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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 |
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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. |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Other |
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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 |
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Intervention | Other: Scars assessment & QOL
Scar assessment and quality of life questionnaires
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Estimated Enrollment |
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
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Sex/Gender |
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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 |
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PRS Account | MediWound Ltd | |||
Verification Date | May 2011 |