Development of Technologies that Address the Complex Architecture of the Face During the Treatment of Severe Facial Burn Injury

Burn injuries to theface present a number of functional and psychological challenges that arisefrom scarring and contracture. Thus, amajor goal of burn and trauma surgeons is to prevent scarring and improvegraftingtechnologies that are used on thecomplextopography of the face. The proposed project builds on previous PhaseII SBIR workthat demonstrated thefeasibility of using a keratin-collagen matrixfor burn treatment thatcould potentially address thesechallenges. This matrix was developed jointly by KeraNetics and Integra LifeSciences and showed optimal mechanical characteristics and promisingefficacy data in a large animal scar model. This project will build on that data by assessingkeratin-Integramatrices under design-control using both in vitro and in vivo performance and required FDA safety testing. The matrix will also betested in a porcinefull thickness120-day burn model to determinecontracture and scarring. The projectgoals areto produce a keratin-Integramatrixthat will prevent scarring as it naturally degrades,reducingthe need for full, painful dressingchanges and the risk ofscarring and contracturein our Wounded Warriors. The outcome of a successful project will be a product ready forFDA submission and commercialization in PhaseIII.