Air Barrier System for the Prevention of Prosthesis-related Infections

描述（由申请人提供）：本项目是在多中心临床试验中评估一种新型装置，空气屏障系统（ABS），以降低假体相关手术部位感染的风险。ABS在术中通过在切口周围创造一个高纯度空气场来保护手术切口，防止空气中的微生物进入切口。正在进行的NIH/SBIR II期研究，在休斯顿DeBakey退伍军人事务医疗中心（VAMC）的单点试验中招募了258名患者，初步结果表明ABS在减少髋关节置换术、脊柱后路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，手术室中较高水平的空气传播微生物与假体相关感染的发生率增加有关，而ABS显著减少了手术过程中这些微生物的存在。Nimbic Systems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院（德克萨斯州刑事司法部门医院）的研究人员和外科医生组成了一个联盟。之所以选择这些机构，是因为在目标手术过程中报告的感染率很高；他们提供广泛的外科服务，并能提供足够的入学人数；患者的随访依从性很高。Nimbic员工和联盟贡献者都将参与研究。这项IIB期研究将在一项扩大到816例手术病例的前瞻性、随机、盲法多中心试验中评估ABS的性能。研究的外科手术将包括全髋关节置换术、创伤相关的髋臼重建、后路固定脊柱融合和假血管移植手术。患者将在研究的前两年入组，CDC指南要求一年的随访期来监测患者潜在的假体相关感染。该项目的主要目的是：(1)比较对照组和ABS组之间种植体相关感染的发生率；(2)确定手术室空气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)确定是否可以构建基于空气CFU水平的风险评估模型来预测感染发生率；(4)评估用户对ABS装置的满意度并开发设备改进。

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.