Air Barrier System for the Reduction of Airborne Particulate and Colony-forming Units (CFU) During Total Shoulder Arthroplasty.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- CFU counts
研究概览
简要总结
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.
详细描述
The Air Barrier System (ABS) is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne CFU and particles at the surgery site during total arthroplasty surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Candidate for total shoulder arthroplasty
排除标准
- •Prior history of infection
- •Revision surgery
- •Screens positive for MRSA
研究组 & 干预措施
Control
In the control arm, the ABS device will be placed as usual on the patient, but the airflow will NOT be activated. Only the technician in the room will be aware whether the device the device is turned on or not.
干预措施: Control (Device)
Air Barrier System
In the experimental (interventional) arm, the ABS device will be placed as usual on the patient, and the airflow will be activated. Only the technician in the room will be aware whether the device is turned on or not.
干预措施: Air Barrier System (Device)
结局指标
主要结局
CFU counts
时间窗: Four months
Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm
Particle counts
时间窗: Four months
Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.
次要结局
未报告次要终点