Operating Room Air Filtration/Sterilization and Surgical Site Infection: A Randomized Multiple Cross-over Cluster Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66,273
- 试验地点
- 2
- 主要终点
- Serious surgical site infections and related complication in previously uninfected surgical inpatients
研究概览
简要总结
Determine whether operating room air filtration and sterilization with the ActivePure system reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery.
详细描述
The investigators primary goal is thus to determine whether supplemental filtering and sterilizing operating room air reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery. The primary outcome will be restricted to inpatients. However, outpatients will be simultaneously enrolled given the trial's cluster design. Sample-size is based on our primary inpatient analysis, N= 66,273 inpatients. Available outpatients will be included for analysis of our secondary outcome which includes both inpatients and outpatients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Identical-looking test devices are either active or inactive. None of the investigators, clinicians, patients, or outcome assessors knows which are which.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients in designated adult operating rooms
- •American Society of Anesthesiologists physical status 1-
- •Surgery lasting at least 1 hour.
排除标准
- 未提供
研究组 & 干预措施
Aerus air sterilization
Aerus air sterilization system will be used in an operating room, in addition to routine room air filtration
干预措施: Functioning Aerus air filtration/sterilization (Device)
Conventional air handling
Only routine room air filtration will be used in an operation room.
干预措施: Deactivated Aerus air filtration/sterilization (Device)
结局指标
主要结局
Serious surgical site infections and related complication in previously uninfected surgical inpatients
时间窗: 30 days after surgery
Composite of serious surgical site infections, infection-related complications, and death in surgical inpatients without present-on-admission composite infection components
次要结局
- Serious surgical site infections and related complication in previously uninfected surgical inpatients and outpatients(30 days after surgery)