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| ID | Type | Description | Link |
|---|---|---|---|
| NL50542.094.14 | Other Identifier | ABR |
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| Name | Class |
|---|---|
| Ernst Reichmann Tissue Biology Research Unit, Zürich | OTHER |
| Seventh Framework Programme | OTHER |
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In this study the efficacy of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. The investigators expect this treatment to provide better outcome regarding scar quality.
Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Patients with with full thickness skin defects will be included in this study. This phase II study aims to investigate the efficacy of the use of this dermal matrix, with regard to scar quality as determined for elasticity at 3 months after treatment. Moreover, graft take (5-7 days after treatment), epithelialisation (5-7 days and 2-3 weeks), and scar quality (3 and 12 months after treatment, as determined for elasticity, colour/pigmentation, and using a subjective scar assessment scale) will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermal substitute with STSG | Experimental | Novomaix dermal substitute in combination with STSG |
|
| STSG alone | No Intervention | STSG alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novomaix dermal substitute in combination with STSG | Device | Novomaix dermal substitute in combination with STSG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS) | Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS) | 3 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Graft take (Subjective assessment by experienced observer) | 5-7 days | |
| Epithelialisation (Subjective assessment by experienced observer) | Subjective assessment by experienced observer | 5-7 days and 2-3 weeks post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Middelkoop, Prof. dr. | Red Cross Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie | Berlin | 12683 | Germany | |||
| Red Cross Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24178984 | Background | Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Buhren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1. |
| Label | URL |
|---|---|
| euroskingraft results | View source |
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part of wound treated with /without dermal template
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participant and assessor are both unaware of location of dermal template
| Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire) | Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire | 12 months |
| Scar quality (As determined with subjective scar assessment scale (POSAS) | As determined with subjective scar assessment scale (POSAS) | 3 and 12 months |
| Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter) | As measured for scar colour and pigmentation using DSM II ColorMeter | 3 and 12 months |
| Beverwijk |
| North Holland |
| 1942 LE |
| Netherlands |
| Children's Hospital Department of Surgery Kinderspital Zurich | Zurich | Switzerland |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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