Air Barrier System to reduce contamination of wounds during surgery

描述（由申请人提供）：（注：本提案中的所有重新提交更新均以斜体表示）本小型企业创新研究（SBIR）II期项目是在初步临床试验期间对旨在降低手术部位感染风险的新型器械“空气屏障系统”进行的评价。在SBIR第一阶段研究中显示，空气屏障系统可将切口部位的菌落形成单位减少约84%，并通过局部高纯度空气场保护手术伤口。多项研究表明，手术部位细菌定植的主要来源是手术室中患者皮肤脱落的葡萄球菌。防止空气传播的细菌进入手术部位的能力是减少术后感染的重要因素，特别是在包含假体的手术中。为了执行这个项目，Nimbic Systems与德克萨斯州休斯顿贝勒医学院/ DeBakey退伍军人事务医疗中心的研究人员和外科医生组成了一个联盟。VAMC是进行这项研究的理想机构，因为它提供广泛的手术服务，目标手术中手术部位感染的发生率超过6%，患者随访依从性高。II期研究的主要目的是在一项扩展至300例手术病例的前瞻性随机双盲先导试验中评价ABS的性能。已选择骨科（全髋关节置换术）、神经外科（腰椎椎板切除术和内固定融合术）和血管外科（股腘动脉旁路移植术）中存在高感染风险的假体植入手术进行研究。该项目的目标是：（1）确定ABS在由多名外科工作人员进行的一系列外科专业中减少CFU污染的有效性，（2）将ABS性能与层流手术环境进行比较，以及（3）检测对照组和实验组之间SSI发生率的临床相关趋势。肯定的II期结果将提供空气屏障系统开始商业化和构建关键前瞻性、随机、多中心临床试验所需的关键数据。这项研究的更广泛的影响是许多类型的手术后手术部位感染的潜在减少。在高风险手术中感染的患者面临相当大的困难，有证据表明，老年人、不富裕的人和非城市人口更有可能死于SSI。治疗高风险手术后发生的手术部位感染的费用每年超过26亿美元，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。 公共卫生相关性：高风险手术后感染手术部位感染（SSI）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死于SSI。治疗高风险手术后发生的手术部位感染的费用每年超过26亿美元，预计到2030年将迅速增长。本项目的目标是进行一项临床试验，以评价一种新型器械“空气屏障系统”在骨科、神经外科和血管外科手术中降低SSI风险的能力。

DESCRIPTION (provided by applicant): (Note: All resubmission updates in this proposal are designated by italics) This Small Business Innovation Research (SBIR) Phase II project is an evaluation of a novel device designed to reduce the risk of surgical site infection, the Air Barrier System", during a pilot clinical trial. The Air Barrier System, shown during SBIR Phase I study to reduce the presence of colony forming units at an incision site by approximately 84%, shields surgical wounds with a localized high-purity air field. Multiple studies have shown that the primary source of surgical site bacterial colonization is Staphylococci shed from the skin of people present in the surgical theatre. The ability to prevent airborne precipitation of bacteria into the surgical site is an important factor in reducing postoperative infection, particularly in procedures incorporating prostheses. To execute this project, Nimbic Systems has formed a consortium with researchers and surgeons at Baylor College of Medicine / DeBakey Veterans Affairs Medical Center in Houston, TX. The VAMC is an ideal institution in which to conduct this research since it performs a broad range of surgical services, the incidence of surgical site infection in the targeted procedures exceeds 6%, and patient follow-up compliance is high. The primary objective of the Phase II research is to evaluate the ABS performance in a prospective randomized, double-blind pilot trial expanded to 300 surgical cases. Prosthesis implantation procedures, presenting high infection risk, in orthopedics (total hip arthroplasty), neurosurgery (lumbar laminectomy with instrumented fusion), and vascular surgery (femoral-popliteal bypass grafting) have been selected for study. The project's aims are to: (1) determine ABS effectiveness at reducing CFU contamination in a range of surgical specialties conducted by multiple surgical staff, (2) compare ABS performance against laminar airflow surgical environments, and (3) detect clinically relevant trends in SSI incidence between the control and experiment groups. Affirmative Phase II results will provide crucial data needed to begin commercialization of the Air Barrier System and to construct a pivotal prospective, randomized, multi-center clinical trial. The broader impact of this research is the potential reduction of surgical site infections after many types of procedures. 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. The cost of treating surgical site infections developing after high-risk surgeries is greater than $2.6 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. PUBLIC HEALTH RELEVANCE: Patients contracting a surgical site infection (SSI) after high-risk surgical procedures face considerable hardships, and evidence shows that elderly, less affluent, and non-urban populations are more likely to succumb to an SSI. The cost of treating surgical site infections developing after high-risk surgeries is greater than $2.6 billion annually and is projected to grow rapidly through the year 2030. The goal of this project is to conduct a clinical trial to evaluate the ability of a novel device, the Air Barrier System", to reduce the risk of SSI in orthopedic, neurosurgery, and vascular surgery procedures.