Research Project
8829075
DESCRIPTION (provided by applicant): Necrotic tissue forms within burns and chronic ulcers, preventing wounds from healing and increasing the risk of infection and sepsis. To remove necrotic tissue from wounds, various types of debridement techniques are utilized, including surgical debridement, enzymatic debridement, autolytic debridement, biological debridement, and mechanical debridement, with surgical and enzymatic debridement being most prevalent. Although surgical debridement is the fastest and the most efficient method for debriding necrotic tissue, this is performed by trained doctors/surgeons. Viable tissue is inevitably debrided because of a lack of a clear border between necrotic tissue and viable tissue, resulting in an enlarged wound area and increased blood loss. Enzymatic debridement, while slower, requires less training and is generally performed by nursing and other clinical staff. Additionally, enzymes can preferentially debride necrotic tissue over viable tissue. Thus, there is a clinical need for a debridement agent that can more rapidly remove necrotic tissue without compromising selectivity, is easy to use, and can control infection. An innovative enzyme-based debridement formulation has shown early promise to fulfill these requirements. The overall goal of this project is to develop a debriding product that can fully debride necrotic tissue faster than existing products, is easy to apply and to remove, and is more compatible with medications commonly taken by seniors. The first specific aim is to develop a stable debridement formulation, determine the ease of application and removal of the formulation, and the ex vivo debridement efficacy compared to existing commercial products. The second specific aim is to determine the compatibility of various commonly used antimicrobials with the debriding process. The third specific aim is to conduct an in vivo study in a porcine full thickness burn wound model to determine if the proposed debridement formulation can accelerate the debridement process and improve wound healing by accelerating epithelialization and granulation tissue formation. The results will be compared to the most commonly used commercial enzymatic debridement product. If successful completion of these specific aims occurs, compositions will be selected for Phase II testing for debridement in second and third degree burn wounds as well as in diabetic foot ulcers. Successful development of this debridement formulation will fulfill a number of unmet needs of current debridement procedures. The final product will clinically simplify debridement of necrotic tissue by being easy to use and to remove, shortening the time required for debridement, in addition to improving wound healing and reducing medical costs.
