Air Barrier System for the Prevention of Prosthesis-related Infections

描述（由申请人提供）：本项目是一项多中心临床试验中对新型器械空气屏障系统（ABS）的评价，旨在降低假体相关手术部位感染的风险。ABS通过在切口周围产生一个高纯度空气场，防止空气传播的微生物进入切口，从而在术中保护手术切口。正在进行的NIH/SBIR II期研究的初步结果表明，在休斯顿DeBakey退伍军人事务医疗中心（VAMC）的单中心试验中招募了258名患者后，ABS在降低髋关节置换术，后路脊柱融合术和假体血管移植手术中假体相关感染的临床发生率方面具有积极的趋势。此外，初步数据趋势表明，手术室中空气微生物水平较高与假体相关感染的发生率增加相关，并且ABS可显著减少手术过程中这些微生物的存在。Nimbic系统公司与休斯顿贝勒医学院（VAMC和Ben Taub综合医院）和加尔维斯顿德克萨斯大学医学分支（德克萨斯州刑事司法部医院）的研究人员和外科医生组成了一个联盟。之所以特别选择这些机构，是因为目标外科手术中报告的感染率很高;它们提供广泛的外科服务，可以提供足够的入组量;患者随访依从性高。进行的研究将包括Nimbic员工和财团贡献者的参与。这项IIB期研究将在一项扩展至816例手术病例的前瞻性、随机、设盲多中心试验中评价ABS的性能。研究的外科手术包括全髋关节置换术、创伤相关髋臼重建、后路脊柱内固定融合术和人工血管移植术。患者将在研究的前两年入组，CDC指南要求一年随访期以监测患者是否存在潜在的假体相关感染。该项目的主要目标是：（1）比较对照组和ABS组之间植入物相关感染的发生率，（2）确定手术室中空气传播微生物水平的增加是否与手术部位感染发生率的增加相关，（3）确定是否可以构建风险评估模型以基于空气传播CFU水平预测感染发生率，（4）评估用户对ABS设备的满意度，并开发设备改进方案。

DESCRIPTION (provided by applicant): This project is an evaluation of a novel device, the Air Barrier System (ABS), to reduce the risk of prosthesis- related surgical site infection in a multi-center clinical trial. The ABS shields surgical incisions intra-operatively by creating a field of high-purity air surrounding an incision that prevents airborne microorganisms from entering the incision. Preliminary findings in the ongoing NIH/SBIR Phase II study, after enrolling 258 patients in a single-site trial at the DeBakey Veterans Affairs Medical Center (VAMC) in Houston, indicate a positive trend for the ABS to reduce the clinical incidence of prosthesis-related infection in hip replacement, posterior spinal fusion, and prosthetic vascular graft procedures. Furthermore, preliminary data trends indicate that higher levels of airborne microorganisms in surgical theatres are correlated to an increased incidence of prosthesis-related infections and that the ABS significantly reduces the presence of these organisms during surgical procedures. Nimbic Systems has formed a consortium with researchers and surgeons at Baylor College of Medicine (VAMC and Ben Taub General hospitals) in Houston and University of Texas Medical Branch at Galveston (Texas Department of Criminal Justice Hospital). These institutions were selected specifically because the reported infection rates in the targeted surgical procedures are high; they perform a broad range of surgical services and can provide adequate enrollment volume; and patient follow-up compliance is high. Research performed will include participation by both Nimbic employees and consortium contributors. This Phase IIB research will evaluate ABS performance in a prospective, randomized, blinded multi-center trial expanded to 816 surgical cases. The surgical procedures studied will include total hip arthroplasty, trauma- related acetabula reconstruction, posterior instrumented spine fusion, and prosthetic vascular graft procedures. Patients will be enrolled during the first two years of the study, and CDC guidelines require a one year follow- up period to monitor patients for potential prosthesis-related infections. The project's key aims are to: (1) compare the incidence of implant-related infections between the control and ABS groups, (2) determine whether increased levels of airborne microorganisms in surgical theatres are correlated to an increase in the incidence of surgical site infections, (3) determine if a risk-assessment model can be constructed to predict the incidence of infection based on airborne CFU levels, (4) evaluate user satisfaction with the ABS device and develop device improvements.