SBIR Phase I: Air Barrier System to reduce contamination of wounds during surgery

该奖项是根据2009年《美国复苏和再投资法案》(Public Law 111-5)资助的。这个小型企业创新研究(SBIR)第一阶段项目将调查目前正在开发的一种设备技术的能力，以防止导致感染的微生物通过空气传播媒介入侵手术部位。到目前为止，在长凳研究和身体手术期间对工作原型进行的研究证实了这样的假设，即与对照组相比，该设备显着减少了手术部位微生物和空气中颗粒物的存在。SBIR第一阶段的资金将允许进行更多的研究，以便在63个手术程序的临床试验中证明该设备的有效性。肯定的第一阶段结果将导致第二阶段研究的预期目标，以确定在更大的多部位试验中，该设备是否可以有效地减少高风险手术中手术部位感染的发生率。这项研究的更广泛影响是潜在地减少手术部位感染，并有助于更好地了解感染媒介。在高风险手术中感染的患者面临着相当大的困难，有证据表明，老年人、不太富裕的人和非城市人口更有可能在假体植入手术后死于SSI。治疗高风险手术后出现的手术部位感染的费用每年超过17亿美元，预计到2030年将迅速增长。正在开发的技术可能会降低医疗保健系统的成本，并防止此类感染造成的人类痛苦。

This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).This Small Business Innovation Research (SBIR) Phase I project will investigate the ability of a device technology currently in development to prevent the intrusion of infection-causing microorganisms into surgery sites via the airborne vector. The research to-date conducted on working prototypes during bench studies and cadaver surgeries corroborates the hypothesis that the device dramatically reduces the presence of microorganisms and airborne particulate at surgery sites versus control groups. SBIR Phase I funding will allow additional research to be conducted in order to demonstrate the device's effectiveness in a clinical trial of 63 surgery procedures. Affirmative Phase I results will lead to the anticipated goal of Phase II research to determine if the device can effectively reduce the incidence of surgical site infections in high-risk surgeries during a larger multi-site trial.The broader impacts of this research are the potential reduction of surgical site infections and the contribution to a better understanding of the vectors of infection. Patients contracting an infection during high-risk procedures face considerable hardships, and evidence shows that elderly, less affluent, and non-urban populations are more likely to succumb to an SSI after prosthesis implant surgeries. The cost of treating surgical site infections developing after high-risk surgeries is greater than $1.7 billion annually and is projected to grow rapidly through the year 2030. The technology under development can potentially reduce cost to the healthcare system and prevent human suffering caused by such infections.