STTR Phase I: Novel Acellular Grafts Containing Rifampin and Minocycline for Single-Stage Reconstruction of Stage II-III Pressure Ulcers

The broader impact /commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to develop a wound care product to heal bed sores or pressure ulcers (PUs). Over 2.5 million Americans, usually older adults, suffer from PUs annually. PUs can be deep wounds, take many months to heal, cause significant pain; if infected, they can lead to sepsis and death. The annual U.S. cost for treatment of all PUs is estimated to be greater than $11 billion. Current treatment options involve surgical reconstruction with skin or skin substitute grafts, which can fail to heal the pressure ulcer because of infection or because the graft was not strong enough. To address these issues, the proposed project will develop a novel skin substitute that is pro-regenerative, stronger, and releases infection-fighting drugs at the surgical site to allow healing. This could benefit physicians and hospitals treating patients with stage II-III PUs (58% of all PUs); the 3-year market potential is over $150 million. The underlying technology of the proposed solution can be used to make novel grafts for treatment of numerous wound types, improving healing and patient quality of life. This Small Business Technology Transfer (STTR) Phase I project focuses on demonstrating the feasibility of this drug-loaded, polymer-impregnated acellular biologic graft (ABG) platform technology. Currently, PUs are surgically reconstructed using skin or skin substitute grafts, like ABGs, which often fail due to infection or lack of mechanical strength. By embedding a polymer hydrogel within an ABG, it can be mechanically strengthened. Furthermore, mixing the polymer with drugs (drug+polyABG) enables a drug delivery system that provides sustained, local release of therapeutic agents such as anti-infectives over a 14-day period. This novel approach simultaneously provides an allogeneic scaffold for patient-mediated tissue regeneration and counters onset of common complications during wound healing. This biocompatible polymer impregnation of ABGs for therapeutic applications has not been performed previously. This Phase I project will demonstrate feasibility drug+polyABG by (1) characterizing drug release and bioactivity in vitro and (2) assessing efficacy in an in vivo mouse model of single-stage reconstruction of stage II-III PUs challenged with topical MRSA. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.