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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01454310 |
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Date of registration:
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15/10/2011 |
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Primary sponsor: |
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Public title:
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An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns
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Scientific title:
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A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01454310 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Austria
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Contacts
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Name:
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Lars P Kamolz, MD, PhD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Vienna |
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Name:
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Maike Keck, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Vienna, Department of Plastic and Reconstructive Surgery |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients older than 18 years of age
- verified deep partial-thickness burns
- early tangential excision of burn wound (3-5 days after trauma)
Exclusion Criteria:
- Pregnancy
- ABSI-Score >13
- Active tumor or immune-mediated disease
- Patient refusal
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Scar Formation
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Wound Healing
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Intervention(s)
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Device: Autologous skin
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Device: Wound coverage by acellular skin substitute
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Primary Outcome(s)
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Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin
[Time Frame: 1 year]
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Secondary Outcome(s)
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Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin
[Time Frame: 1 year]
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Secondary ID(s)
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SUPRA-VS-STSG-2010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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