There is need for an improved, hemostatic dressing to control renal hemorrhage associated with new nephron-sparing endourologic procedures such as laparoscopic partial nephrectomy (LPN). Our surgical laboratory and small business (KOAG) has developed a cost-effective, microfibrillar chitosan hemostat approved by the FDA for topical use. Chitosan is sourced from chitin, earth's second most natural abundant biopolymer and seafood industry waste product. Chitosan is a biodegradable polyglucosamine polymer that requires depyrogenation before implantation in humans. Our goal is to meet the need for a cost-effective endourologic resorbable hemostat by innovative nitrogen plasma detoxification of microfibrillar chitosan. Our Phase I SBIR study is designed to optimize a non-thermal nitrogen plasma depyrogenation method and simultaneously increase mucoadhesivity and hemostatic effectiveness by surface nitrogenation. A safety and efficacy study of the biocompatibility and hemostatic effectiveness of depyrogenated-nitrogenated microfibrillar chitosan will be conducted in the porcine LPN model as a Phase I study with proof of safety and efficacy. A head-to-head comparison of our product to other available LPN hemostats will be conducted as a Phase II study.
Development of an economical, resorbable hemostat that can be applied endoscopically will facilitate advances in minimal invasive nephron sparing surgery. An innovative detoxification procedure - low temperature nitrogen plasma - will be used to detoxify microfibrillar chitosan for implantation.
