Description:
OBJECTIVE: The objective of this effort is to develop new innovative technologies that address the complex architecture of the face to facilitate the treatment, effectiveness, recovery and outcomes from treatment for severe facial burn injury. DESCRIPTION: Here we recognize 450,000 burn injuries requiring medical treatment occur in the U.S. each year. Approximately 55% of 45,000 of acute hospitalizations cases require admission to specialized burn units for treatment. Burn injuries also complicate approximately 5% to 10% of contemporary combat casualties not returned to duty within 72 hours. Approximately 77% of treated burn injuries sustained from combat explosions during the current armed conflicts involved the face. Such cases often exhibit spontaneous epithelialization that result in the formation of scars which may subsequently lead to contracture. A contracture scar is a permanent tightening of the skin where normal elastic connective tissue is replaced with inelastic fibrous tissue. The current unmet need when treating such severe burn injuries lies in scar prevention and improving current grafting technologies on the complex topography of the face. PHASE I: Conceptualize and design an innovative solution to facilitate wound healing and restoring facial aesthetics following severe facial burn injuries. Such technologies should improve the application, retention, or performance of autografts, allografts, dermal equivalents or skin equivalents when applied to deep-partial thickness to full thickness burns of the facial region leading to improvement of the functional and cosmetic outcomes. The required Phase I deliverables will include: 1) a research design for engineering the proposed technology and 2) A preliminary prototype with limited testing to demonstrate in vitro proof-of-concept evidence (to be executed at Phase I). Other supportive data resulting from in vivo proof-of-feasibility studies may also be provided during this 6-month Phase I, $100K (max) effort. PHASE II: The researcher shall design, develop, test, finalize and validate the practical implementation of the prototype technology that implements the Phase I methodology to prevent scar formation and facilitate wound healing at a burn injury site over this 2-year, $1.0M (max) effort. The researcher shall also describe in detail the transition plan for the Phase III effort. PHASE III DUAL USE APPLICATIONS: Plans on the commercialization/technology transition and regulatory pathway should be executed here and lead to FDA clearance/approval. They include: 1) identifying a relevant patient population for clinical testing to evaluate safety and efficacy and 2) GMP manufacturing sufficient materials for evaluation. The small business should also provide a strategy to secure additional funding from non-SBIR government sources and /or the private sector to support these efforts. Military application: The desired therapy will allow military practitioners to apply the therapy. Commercial application: Healthcare professionals world-wide could utilize this product as a therapy meant to improve the standard of care presently available to burn patients. REFERENCES: 1."Burn Incidents Fact Sheet."American Burn Association, 2011. http://www.ameriburn.org/resources_factsheet.php 2."Burn Injuries."JAMA, October 28, 2009; Vol 302, No. 16; p 1828. http://jama.ama-assn.org/content/302/16/1828.full.pdf 3."Burns."MedLinePlus. http://
