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The purpose of the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for another additional option of wound coverage in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial skin substitute is at least not inferior to autologous skin grafts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acellular skin substitute | Experimental |
| |
| Autologous skin graft | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound coverage by acellular skin substitute | Device | Burn wounds are covered by an acellular skin substitute and remains 10-14 days that peals away in line with re-epithelialisation |
| Measure | Description | Time Frame |
|---|---|---|
| Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin | Time to complete re-epithelialisation measured in days after surgery | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin | Quality of the skin is measured two-fold:
| 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars P Kamolz, MD, PhD, MSc | Medical University of Vienna | Study Chair |
| Maike Keck, MD | Medical University of Vienna, Department of Plastic and Reconstructive Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Burn Center, Department of Plastic and Reconstructive Surgery | Vienna | State of Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17084030 | Background | Uhlig C, Rapp M, Hartmann B, Hierlemann H, Planck H, Dittel KK. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. Burns. 2007 Mar;33(2):221-9. doi: 10.1016/j.burns.2006.04.024. Epub 2006 Nov 2. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
| Autologous skin | Device | Matched burn wound is covered by autologous skin after tangential excision. |
|