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| ID | Type | Description | Link |
|---|---|---|---|
| NL42113.094.12 | 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 safety and feasibility 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. We expect this treatment to be safe, and 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. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality 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 |
|---|---|---|
| Graft take (experimental vs control area) | Subjective assessment of two experienced observers | 5-7 days postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Epithelialization | Subjective assessment of two experienced observers | 5-7 and 18 ± 2 days days postoperative |
| Complication rate | Measurement of re-operations, infection rate by culture swabs |
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Inclusion Criteria:
Age ≥18 years
Full thickness skin defects of 50 cm2 or more, but <50% TBSA
Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted
Informed consent by the patient
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. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Up to 12 months postoperative |
| Scar quality | As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale | 3 months |
| Scar quality | As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale | 6 months |
| Scar quality | As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale | 9 months |
| Scar quality | As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale | 12 months |
| Beverwijk |
| North Holland |
| 1942 LE |
| Netherlands |