Research Project
9408716
Project Summary Healthcare associated infections (HAIs) pose significant harm to neonates. HAIs are associated with increased risk of death and longer hospital stays for the infant as well as poor neurological developmental and physical growth in the early childhood years. According to a 2011 CDC report, there were an estimated 722,000 HAIs in U.S acute care hospitals, resulting in 75,000 deaths and up to $20 billion in healthcare costs, yearly. In hospitals and other clinical environments, transfer of pathogens on the hands of healthcare workers is considered an important mechanism for passing pathogenic organisms to unsuspecting patients. The importance of good hand hygiene in clinical environments is well established and handwashing or the use of alcohol-containing rubs are methods that generally work, but each has significant limitations including: the amount of time required is prohibitive; alcohol rubs do not have activity against Clostridium difficile spores or non-enveloped viruses like norovirus; current hand hygiene methods are subject to significant variability. The primary objective of this project is to generate the efficacy and safety data needed to apply hypochlorous acid solutions in a novel automated hand sanitization system that will be fast (3-5s), will leave hands dry, and will be located near the patient, especially infants, to significantly improve the frequency and quality of hand hygiene procedures. Previously LivOnyx demonstrated feasibility of the thinSpray fluid dispensing system using a minute volume of various antiseptic spray to quickly inactivate clinically-relevant bacterial pathogens, such as susceptible Escherichia coli, Staphylococcus aureus, Acinetobacter baumannii, Enterococcus faecalis and Pseudomonas aeruginosa in addition to vancomycin resistant E. faecium, ampicillin resistant E. coli, multidrug resistant Klebsiella pneumoniae, and methicillin resistant S. aureus. LivOnyx proposes to investigate the following specific aims to expand on previous work. Specific Aim 1 Quantification of hypochlorous acid antiseptic efficacy against clinically-relevant bacterial pathogens. This phase of the project uses a large volume assay to determine minimum antiseptic concentrations and contact times required to achieve defined reductions of bacteria deposited onto porous surfaces. Specific Aim 2: Evaluation of a cultured human skin model for irritation and toxicity following exposure to aqueous hypochlorous acid solutions. This phase of the project is based on use of the MatTek Epiderm? product to predict key aspects of the response of human skin to hypochlorous acid solutions. Initial assessments of aqueous hypochlorous acid solutions will be conducted according to MatTek's In Vitro EpiDerm? Skin Irritation Test protocol.Specific Aim 3: Development of an engineering test-bed that can spray a minute thickness film of hypochlorous acid, uniformly across mock hand features to enable quantification of the reduction of bacteria on 3-d surfaces. Although we have seen promising results using our current test-bed to spray antiseptic reagent on small flat surfaces, an eventual hand-sanitizing product must achieve efficacy on significantly larger 3-d surfaces with curvature. The successful completion of this proposal will position the company to continue development of innovative, better hand hygiene products for the neonatal and broader hospital markets.
