The goal of this Phase I SBIR proposal is to test the feasibility of an antimicrobial tissue scaffolding hydrogel matrix in eliminating infecting bacteril pathogens and promoting wound regeneration. Preventing and treating wound infections and regeneration are becoming less effective due to the rapid rise in Multi-drug Resistant Organisms (MDRO). A recent study by Pada et al. (2011) reported that patients with MRSA-infected wounds were 10.2 times more likely to die during their hospitalization, had 4.6 times longer hospitalization, and incurred 4 times higher hospitalization costs when compared to patients without infection. Patients who do survive MRSA (multidrug-resistant Staphylococcus aureus) often spend months in the hospital and endure repeated surgeries to cut out infected tissue. In 1974, 2% of staph infections were MRSA. By 1995, the number had climbed to 22%, and now is over 60% and still rising. The proposed product will treat wounds by both (i) preventing infection through a unique mechanism of action that is broad spectrum antibacterial, and (2) it will promote tissue regeneration by providing cell attachment sites within the scaffolding matrix. Additionally, the gel formulation of the proposed product allows it to be flowable and conform to unique wound shapes and depths easily, so it can be administered quickly by any healthcare professional. To establish the feasibility, we propose the following two specific aims:
Specific aim 1) Demonstrate the therapeutic in vivo efficacy of the product to eliminate infection from a wound in a mouse model infected with Staphylococcus aureus (S. aureus). Milestones: Show elimination of S. aureus from wounds to 99.9% or below as quantified by bacterial titers Specific aim 2) Demonstrate the in vivo efficacy of the hydrogel to promote healing of full-thickness dorsal excisional wounds in swine. Milestones: Show accelerated wound healing by day 14. In SBIR Phase II, we will validate the hydrogel in an infected wound healing swine model, establish GMP manufacturing, and execute GLP studies in preparation for our FDA submission.
The proposed product is a flowable, antimicrobial skin scaffolding matrix that will both promote regrowth of patient tissue to close a wound, while eliminating bacteria through direct cell membrane disruption. The product is designed to incorporate three major benefits in one material: void filling scaffold, cell compatibility and brod spectrum antimicrobial effects, all of which are crucial for wound closure. The product is easy to administer as an in-topical skin substitute. This product could mitigate the 100,000 amputations, 1.7 million infections, and 99,000 deaths associated with poor wound closure and antibiotic resistance annually
