A Phase 3 interventional study of dermal matrix and Split skin graft in Burns, sponsored by Association of Dutch Burn Centres. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-24.
Sponsored by Association of Dutch Burn Centres · Phase 3, Interventional, and Treatment
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 86 is above the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Association of Dutch Burn Centres is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Other: dermal matrix · Device: VAC therapy (KCI)
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.
Other: dermal matrix
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.
Device: VAC therapy (KCI)
After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5.
Procedure: Split skin graft
1mm thickness matrix composed of collagen-elastin hydrolosate
Also known as: Matriderm
VAC therapy for 3-5 days 125mmHg
skin elasticity parameters (representing scar quality)
Time frame: after 3 months
take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer)
Time frame: after 3 months
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Association of Dutch Burn Centres