KeraStat(R) Burn Gel and Halofuginone to Prevent Scar Contracture after Burn Injuries

No currently available burn product has shown efficacy in substantially decreasing wound healing time and preventing scar formation. The goals of this Phase II proposal are to expand on the results obtained in the Phase I study that showed that (1) halofuginone inhibited collagen-mediated contracture in dermal fibroblasts and (2) the presence of the keratin in the KeraStat burn product results in an attenuation of the cellular injury response following UVB irradiation. The proposed Phase II project will test two potential solutions (KeraStat® and Halogel) to determine their efficacy in reducing time to wound closure and decreasing scarring in a porcine burn healing and scarring model. Following this in vivo efficacy testing, we will further expand to test the efficacy of KeraStat for reducing time to wound closure and for scar prevention in an investigator-initiated 60 patient human clinical trial in partial thickness burn patients. Together, these studies will allow KeraNetics to market and sell the KeraStat product to both the Department of Defense and to civilian burn centers to treat patients and Soldiers with debilitating burn wounds and scars