Stratatech Corporation has developed a novel cultured skin substitute tissue, StrataGraft™ skin tissue, for the temporary management of severe skin wounds prior to autografting. The development and optimization of StrataGraft™ tissue was funded in part by the Phase I portion of this SBIR project. StrataGraft™ tissue is a living combination skin substitute with a fully-stratified epidermal layer which imparts permeability barrier function comparable to that of native epidermis. The FDA has approved a Phase I/II clinical trial ( IND #10110) for Stratatech to evaluate the safety and efficacy of StrataGraft™ skin tissue as an alternative to cadaver skin in the temporary management of severe skin defects requiring surgical intervention. This Phase II SBIR proposal is designed to build on the success of the Phase I project by performing a clinical evaluation of StrataGraft™ skin tissue. Successful completion of this Phase I/II clinical trial will position Stratatech to conduct a pivotal Phase III clinical trial, leading to the ultimate commercialization of StrataGraft™ skin tissue as an improved therapy for the management of burns and other severe skin trauma. The clinical aspects of this study will be performed at the University of Wisconsin – Madison under the direction of Dr. Michael Schurr.