SBIR-STTR Award

Infection in areas of bone injury are a serious consideration in the field of trauma surgery and orthopaedic medicine. The combination of regenerative medicine and controlled drug delivery offers great potential to improve on the current standard of care. Presently, bone infection secondary to osteomyelitis and non-union are treated in a two-stage protocol wherein the first step requires placement of antibiotic impregnated beads, followed by a second step involving removal of the beads and bone grafting. We propose to validate the use of a new bioceramic graft that features controlled delivery of antibiotics and that would require only a single stage operational protocol. In preliminary tests, we have shown that keratin biomaterials are biocompatible, osteoconductive, and able to function as a drug delivery matrix. By further developing this technology into a keratin bioceramic antibiotic putty (KBAP), we endeavor to create a bone graft substitute that is biocompatible, antibiotic, osteoconductive and osteoinductive, as well as moldable, formable, inexpensive, and able to be stored at room temperature. In this Phase I program, we will use an optimized drug delivery system to develop the KBAP and validate its efficacy in cell and microbial culture models

Extremity fractures are a significant concern in both the civilian and military populations. In the military experience, extremity fractures can sometimes comprise the majority of peacetime orthopaedic injuries. During armed conflict, bone trauma from penetrating missiles is similarly significant, as the experience in the Persian Gulf and Croatia has shown. Anti-personnel mines and improvised explosive devices inflict considerable hard tissue damage in the feet and legs, resulting in substantial bone loss in these highly contaminated wounds. The current standard of care requires two procedures, one to aggressively treat the infection and a second to repair the bone. Development of an improved bone graft substitute that combines antibiotic release with a high bone regenerative activity would be a significant improvement in orthopaedic medicine. In this program, we propose to test a keratin bioceramic antibiotic putty that provides osteoconductivity, osteoinductivity, and controlled antibiotic release. This putty, comprised of a keratin hydrogel with ceramic filler, will incorporate controlled and sustained antibiotic release. The KBAP will be able to be formed into shapes and pressed into a bony defect site, and will provide immediate and prophylactic antibiotic therapy as well as an osteoconductive and osteoinductive environment for bone regeneration in a single-stage operational protocol.

Keywords:
KERATIN, GRAFT, ANTIBIOTIC, DRUG DELIVERY SYSTEM, BIOMATERIAL