Phase: CE approved - Clinical Multicenter Study ongoing
The regeneration of full thickness skin defects after plastic reconstructive surgery (i.e. scar excisions) or burn injury is only successful if both the epidermis and the dermis show adequate regeneration. Epidermal regeneration is a clinically established procedure nowadays, either through split skin transplantation (mesh graft) or application of cultured keratinocytes. The healing of these wounds is still complicated by the lack of a dermal component resulting in a poor functional and cosmetic outcome due to (hypertrophic) scar formation and contraction.
The Novomaix dermal regeneration matrix is intended to aid in the healing of full thickness skin defects. The Novomaix dermal regeneration matrix is intended to stimulate the regeneration of dermal tissue as a basis for the attachment of autologous split-skin mesh grafts or cultured keratinocyte sheets. The aim of the treatment is to achieve skin regeneration with less scarring and less wound contraction when compared to epidermal regeneration alone.
The preclinical developments were performed in close cooperation with Prof. Middelkoop (Free University Amsterdam, Burn Wound Center Beverwijk).
The CE mark for Novomaix was received in 2013.
Currently a multicenter study with Novomaix is ongoing as a part of the European EuroSkinGraft project => Novomaix Clinical Trial
The project EuroSkinGraft deals with a novel generation of skin substitutes to clinically treat a broad spectrum of severe skin defects. Burn wound centers in Switzerland, The Netherlands, and Germany are performing clinical studies to compare different innovative treatment concepts for full thickness dermal wounds. EuroSkinGraft is coordinated by PD Dr. Ernst Reichmann, University of Zurich.
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