Intravascular Port and Disinfection System (PortProtek)

血管内输液港和消毒系统 (PortProtek)

• 批准号: 10081970
• 负责人: Patrick Tennican
• 金额: $ 25.16万
• 依托单位: HYPROTEK, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-19 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10081970
• 关键词: Acinetobacter baumannii; Address; Adult; Affect; Bacteria; Bacterial Infections; Bacterial Spores; Biocide; Blood Circulation; Burn injury; Catheter-related bloodstream infection; Catheters; Cause of Death; Cells; Cessation of life; Chemicals; Chlorhexidine; Clinical; Clinical Research; Clostridium difficile; Communicable Diseases; Development; Disinfectants; Disinfection; Drug Delivery Systems; Early Intervention; Edetic Acid; Educational process of instructing; Effectiveness; Elasticity; Elements; Ethanol; Flushing; Gluconates; Growth; Hospital Costs; Hour; Human; Hydrogen Peroxide; Individual; Industry; Infant; Infection; Infection prevention; International; Intravenous; Investigation; Laboratory Research; Legal patent; Medical; Medical Device; Microbial Biofilms; Morbidity - disease rate; Multi-Drug Resistance; Multidrug-resistant Acinetobacter; Mycoses; Nosocomial Infections; Organism; Patients; Play; Porifera; Prevention; Preventive Intervention; Pseudomonas aeruginosa; Reagent; Reporting; Reproduction spores; Research; Residual state; Role; Safety; Saline; Sepsis; Source; Specialist; Sterility; Surface; Surgical Wound Infection; Swab; Syringes; System; Technology; Testing; Traumatic injury; Vascular blood supply; Wound Infection; Yeasts; acute toxicity; antimicrobial; base; colistin resistance; cost; economic cost; efficacy testing; experience; fungus; liquid formulation; methicillin resistant Staphylococcus aureus; microorganism; mortality; multi-drug resistant pathogen; novel; pathogen; pediatric patients; prevent; safety testing; small molecule

ABSTRACT Hospital acquired infections (HAIs), and in particular catheter related bloodstream infections (CRBSIs), are a major cause of mortality, morbidity and economic costs in the U.S. and throughout the world. These infections can be enormously damaging, resulting in ~24,000 deaths and hospitalization costs of ~$2 billion per year in the U.S. alone, as well as significant residual morbidity. Many HAIs are preventable. Hyprotek's technology is already playing an active role in the prevention of HAIs. Commercial use of a sterile saline flush syringe and disinfecting cap system, SwabFlush® is widely marketed. Disinfecting systems currently on the market are simple IV port caps containing ethanol as biocide, fail to address certain key problems. Ethanol solutions do not penetrate the biofilms formed by significant pathogens, or even prevent their formation. Consequently, they are ineffective in preventing or eradicating bacterial and fungal infections of IV ports from pathogens such as methicillin resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, and, colistin resistant and multi-drug resistant (MDR) Acinetobacter baumannii. Ethanol is ineffective against spore-forming bacteria such as Clostridium difficile. Concentrations of ethanol needed to be effective as a single disinfectant can be risky for infants and other weakened patients in cases it enters the bloodstream. Finally, ethanol in high concentrations can damage the materials commonly used in catheter tubing. Hyprotek has developed and patented a system, PortProtek®, comprising a flush or lock solution syringe, one (or more) removable Luer lock cap(s) and a sponge saturated with Hyprotek's patented High Level Disinfectant (HLD) solution. Based on years of Hyprotek's testing, HLD is both safe for use and highly effective against pathogens not prevented or treated by ethanol or chlorhexidine gluconate disinfectants. Hyprotek's HLD comprises three reagents; ethylenediaminetetraacetic acid (EDTA), hydrogen peroxide and ethanol. Each component individually has some efficacy against the sources of infections. However, it is Hyprotek's unique and patented combination that is proving to be uniquely powerful in testing to date against planktonic (free-floating) bacteria, yeast and bacterial spores. The proposed investigation is intended to develop further evidence of the safety and efficacy of Hyprotek's HLD. While each of the ingredients in the HLD is deemed safe by the FDA, Hyprotek will conduct further testing of the ingredients in combination. The safety testing will also include the further examination of the effects of Hyprotek's HLD on the hardware elements in the company’s PortProtek system and on common catheter tubing materials. The latter is a component that concentrated ethanol degrades, but should not be affected by the much lower levels of concentration of ethanol in the Hyprotek combination of ingredients.

抽象的 医院获得性感染 (HAI)，特别是导管相关血流感染 (CRBSI)， 是美国和全世界死亡、发病和经济损失的主要原因。 感染可能造成巨大破坏，导致约 24,000 人死亡，每人住院费用约 20 亿美元 仅在美国一年，以及显着的残余发病率。 许多医院感染是可以预防的，Hyprotek 的技术已经在预防医院感染方面发挥了积极作用。 商业用途的无菌盐水冲洗注射器和消毒帽系统 SwabFlush® 已广泛销售。 目前市场上的消毒系统都是简单的静脉端口盖，含有乙醇作为杀菌剂，未能解决 某些关键问题是乙醇溶液不能渗透重要病原体形成的生物膜，甚至不能渗透。 它们无法有效预防或根除细菌和真菌。 静脉注射端口感染病原体，例如耐甲氧西林金黄色葡萄球菌 (MRSA)， 铜绿假单胞菌、耐多粘菌素和多重耐药 (MDR) 鲍曼不动杆菌。 乙醇对艰难梭菌等孢子形成细菌无效。 需要有效，因为单一消毒剂可能对婴儿和其他虚弱患者产生风险 最后，高浓度的乙醇会损坏常用的材料。 导管管材。 Hyprotek 开发了 PortProtek® 系统并获得专利，该系统包括冲洗或锁液注射器、一个 （或多个）可拆卸鲁尔锁帽和浸有 Hyprotek 专利高水平消毒剂的海绵 (HLD) 解决方案基于 Hyprotek 多年的测试，HLD 既使用安全，又非常有效。 乙醇或葡萄糖酸氯己定消毒剂无法预防或治疗的病原体。 Hyprotek 的 HLD 包含三种试剂：乙二胺四乙酸 (EDTA)、过氧化氢和 乙醇的每种成分都对感染源有一定的功效。 Hyprotek 独特的专利组合在迄今为止的测试中被证明具有独特的强大功能 浮游（自由漂浮）细菌、酵母和细菌孢子。 拟议的调查旨在进一步证明 Hyprotek HLD 的安全性和有效性。 虽然 HLD 中的每种成分均被 FDA 认为是安全的，但 Hyprotek 仍将对其进行进一步测试 安全性测试还将包括进一步检查 Hyprotek 的效果。 HLD 应用于该公司 PortProtek 系统中的硬件元件和常见导管材料。 后者是浓乙醇降解的成分，但不应受到低得多的影响。 Hyprotek 成分组合中乙醇的浓度水平。