Burns Clinical Trial
Official title:
Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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