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| Name | Class |
|---|---|
| Dutch Burnwound Foundation, Netherland | UNKNOWN |
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The application of Glyaderm for skin restoration intends to provide a more stable wound closure with enhanced pliability and function of the skin and a more favourable scar. The dermal substitute would be affordable for widespread application in full thickness skin defects and burns.
Patients with burn wounds or large full thickness wounds will be evaluated before enrollment. All burn wounds that are not clearly full thickness on clinical assessment will be treated during the first 48 hours with a hydrocolloid paste and covered with a paraffin gauze dressing. This hydrocolloid paste combined with paraffin gauze will ensure maintenance of a moist wound environment for the first 48 hours prior to assessment by LDI and randomization. This is the standard treatment for all burns admitted to the Ghent Burn Centre.
Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for LDI, the burn wounds will be meticulously debrided during dressing changes. LDI is most reliable between 48-72 hours. Patients whose burn wounds meet the inclusion criteria, i.e. full thickness burns with LDI values < 200 will be randomized to receive either GLYADERM and split skin graft versus split skin graft alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glyaderm and split skin graft | Experimental | Full thickness defects treated with Glyaderm and split skin graft. |
|
| Split skin graft alone | Active Comparator | Full thickness defects treated with split skin graft alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glyaderm and split skin graft | Procedure | Full thickness defects treated with Glyaderm and split skin graft. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of healing time and percentage of autograft survival | After one week | |
| Comparison in bacterial control in full thickness defects | On day 3,5 an 7 post application of Glyaderm | |
| To assess the monitoring of dermal substitute ingrowth with Laser Doppler Imaging | On day 3, 5 and 7 post application of Glyaderm |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the functional and cosmetic outcome of skin restoration of full thickness defects treated with Glyaderm and split skin graft versus split skin graft alone | 1 month, 3, 6 and 12 months post wound closure | |
| Cost-effectiveness and Health related quality of life (i.e. cost utility analysis) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stan Monstrey, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37143955 | Derived | De Decker I, Hoeksema H, Verbelen J, De Coninck P, Speeckaert M, De Schepper S, Blondeel P, Pirayesh A, Monstrey S, Claes KEY. A single-stage bilayered skin reconstruction using Glyaderm(R) as an acellular dermal regeneration template results in improved scar quality: an intra-individual randomized controlled trial. Burns Trauma. 2023 May 2;11:tkad015. doi: 10.1093/burnst/tkad015. eCollection 2023. |
| Label | URL |
|---|---|
| website of the University Hospital Ghent | View source |
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| Split skin graft alone. | Procedure | Full thickness defects treated with split skin graft alone. |
|
| 1 month, 3, 6 and 12 months post wound closure |