Air Barrier System to reduce contamination of wounds during surgery

描述（由申请人提供）：（注：本提案中所有重新提交的更新以斜体指定）该小企业创新研究（SBIR）二期项目是在试点临床试验期间对一种旨在降低手术部位感染风险的新型设备“空气屏障系统”进行评估。在SBIR一期研究中，空气屏障系统显示，切口部位菌落形成单位的存在减少了约84%，用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从手术室患者皮肤脱落的葡萄球菌。防止空气中细菌进入手术部位的能力是减少术后感染的一个重要因素，特别是在植入假体的手术中。为了执行该项目，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是开展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大到300例手术病例的前瞻性随机、双盲先导试验中评估ABS的性能。在骨科（全髋关节置换术）、神经外科（腰椎椎板切除术伴器械融合术）和血管外科（股腘动脉旁路移植术）中，假体植入手术具有较高的感染风险。该项目的目的是：(1)确定ABS在由多个外科医生进行的一系列外科专业中减少CFU污染的有效性；(2)比较ABS在层流手术环境中的性能；(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期结果将提供开始空气屏障系统商业化所需的关键数据，并构建关键的前瞻性、随机、多中心临床试验。这项研究的更广泛的影响是在许多类型的手术后手术部位感染的潜在减少。在高风险手术过程中感染的患者面临相当大的困难，有证据表明，老年人、不太富裕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。这项正在开发的技术可以潜在地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。

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.