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The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months.
Additionally, an increase of the take of graft and improvement of scar assessment scale, scar colour/pigmentation and time to complete wound closure, is expected.
The standard therapy for full thickness wounds is transplantation with a split thickness skin graft. However, scars usually develop as a result of this therapy. Previous research has demonstrated an improvement of scar quality if a dermal substitute was applied in combination with a split skin graft in reconstructive wounds, but not so much in burn wounds. One of the problems in burn wounds was the retarded outgrowth of the skin graft when a dermal substitute was applied in a one step procedure with the graft. Since then, application of topical negative pressure has demonstrated that the take and outgrowth of a skin graft can be improved by this technique. It now seems feasible to combine these two technologies in order to improve the quality of healing of burn wounds in the acute phase of healing.
Aim of the study is to investigate if application of a dermal substitute in combination with topical negative pressure can improve the quality of the scar in burn wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days. |
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| 2 | Experimental | After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5. |
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| 3 | Experimental | After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days. |
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| 4 | Active Comparator | After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dermal matrix | Other | 1mm thickness matrix composed of collagen-elastin hydrolosate |
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| Measure | Description | Time Frame |
|---|---|---|
| skin elasticity parameters (representing scar quality) | after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer) | after 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Middelkoop, Professor | Association of Dutch Burn Centres (ADBC) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red Cross Hospital | Beverwijk | North Holland | 1942 LE | Netherlands |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C532298 | matriderm |
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| Split skin graft | Procedure |
|
| VAC therapy (KCI) | Device | VAC therapy for 3-5 days 125mmHg |
|