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临床试验/NCT00972153
NCT00972153已完成不适用

Reduction of Airborne Particulate in the Surgical Field Using Directed Local Airflow

Nimbic Systems, LLC2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2009年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
2
主要终点
Surgery Site CFU Density

研究概览

简要总结

The objective of this study is to determine whether the Air Barrier System device reduces airborne particulate and airborne colony forming units present at a surgery site.

详细描述

The Air Barrier System 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 Air Barrier System can reduce the presence of airborne colony-forming units (e.g. bacteria colonies) and particulate at the surgery site.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Candidate for primary total hip arthroplasty

排除标准

  • Prior history of infection
  • Revision arthroplasty
  • Screens positive for MRSA
  • Undergoing hemiarthroplasty or resurfacing

结局指标

主要结局

Surgery Site CFU Density

时间窗: Ten minute intervals throughout surgery

Colony forming unit counts were collected from the air within 5 cm of the surgical wound using a bioaerosol "slit" sampling device. Air was drawn through a sterile PVC tubing located at the incision and impacted upon media (TSA 5% sheep's blood) plates located in the sampling device. The plates were exchanged every 10 minutes throughout the procedure. Values are presented as CFU/cubic meter.

次要结局

  • Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter(Ten minute intervals throughout surgery)

研究者

发起方
Nimbic Systems, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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