Tissue Engineering by a Non-Biologic Skin Substitute

DESCRIPTION (provided by applicant): Wound healing remains a formidable challenge to physicians and health care providers when there is full thickness skin loss. Wounds requiring medical treatment are increasing at a phenomenal rate. While skin grafting is the "gold standard" for treating wounds not candidates for primary or flap closure, skin grafting is expensive, inflicts an additional wound, requires anesthesia, can produce undesirable results, such as graft necrosis, color differences, contracture, infection, etc. Many dressings and treatments are available to attempt to "close" an open wound. Low Technology Dressings (LTDs) are commodity type products, made in high volume, borrowed from industry, and are generally low-cost, widely available and utilized. Examples are Tegaderm(r)(occlusive), Telfa(r) (non-stick), and hydrogels (hydrophilic gels). Seare BioMatrix Systems, Inc. has licensed rights to develop the patents (four) to a biomaterials fabrication technology, SeareMatrix(r) Technology (SM (r)T) exclusively for "Wound Healing". It creates a unique, 3- dimensional, open-cell porosity most useful when made in silicone rubbers. It has been very successful for implant and percutaneous applications where we have data that it promotes larger caliber vessels, including lymphatics, within neo-vascularized tissue ingrowth, adjacent to and within the implant, in a loose collagen matrix, with a benign histiocytic response, and minimal or no capsule at the tissue-implant interface. We propose to study our SM(r) wound dressings for use as temporary skin substitutes, treating 22 mm full thickness wound (FT) defects in four young farm pigs, compared to 1 LTD (Tegaderm(r)) utilizing an open wound and a full-thickness skin graft as negative and positive controls. We propose to obtain data to show our product is superior to the chosen LTD (Tegaderm ) and the negative control in its ability in HEALING WOUNDS to: 1). Function as a temporary skin substitute by, initially and at early dressing changes, attaching to FT wound defects, 2). Retard microbial colonization on FT wounds at 7 days, and in HEALED WOUNDS to:3). Reduce the final measured wound contraction, 4). Promote clinical stratified epithelial regeneration, & 5). Histologically, promote vascularity, including larger caliber vessels, reduce the amount of acute inflammation, provide debridement (less residual tattoo ink) and promote a thicker and stratified neo-epithelium, In light of our preliminary implant and percutaneous access studies, and our recent, but limited wound healing data, and our team, we believe that we can prove our proposed aims, and that this will then have a significant impact on our ability to understand its uses, and to market and make claims for our product.