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临床试验/NCT02695368
NCT02695368已完成不适用

The Effect of Air-filtration Through a Plasma Chamber on the Incidence of Surgical Site Infections in Orthopaedic Surgery: a Double-blind, Randomized, Controlled Trial

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 45,000 人开始时间: 2017年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45,000
试验地点
2
主要终点
Number of patients with surgical site infection after orthopaedic surgery, defined as any of the following: using antibiotics targeting Staphylococcus aureus, having ICD-codes or surgery codes indicating postoperative infection.

研究概览

简要总结

The study is a multicenter, double-blind, randomized, controlled trial conducted at six major university and teaching hospitals with a catchment population of approximately 2 million. In the current study it has been hypothesized that a non-invasive air cleaner utilizing a plasma chamber can significantly reduce the incidence of surgical site infections (SSIs).

详细描述

Despite operating in clean theaters, surface sterilization, and antibiotics, surgical site infections (SSI) after orthopaedic surgery have an estimated incidence of 1-4%. This feared complication is associated with long-term antibiotics, repeated surgeries, prolonged hospital stays, economic burden and a poorer end result for individual patients. It is therefore of great importance to prevent SSI.While skin bacteria and contaminated surfaces have generally been claimed to be the main cause of infections, there are estimates that approximately 20% of hospital-acquired infections are air-transmitted, making this an interesting intervention target. Novaerus is an air-cleaner that sterilizes the air particles through a plasma chamber. Air in the operating theatre is pumped through the chamber (80-380 m3/Hr) and by using a small current it transforms the gas in the vicinity of the electrode into plasmaand eradicates any bacteria that pass through.The small size of the machine allows it to fit into any operating theater without interfering with existing equipment. This technology can reduce the number of colony forming units (CFU) when in hospital settings. In non-randomized settings it has been correlated to reduced respiratory infections, reduced personnel sick-leave, and absence of severe infectious outbreaks. Its effect has not been validated in randomized controlled trials. Both local and national registry data will be used according to availability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients that undergo a 30 minute or longer orthopaedic surgery

排除标准

  • The following surgeries will be excluded: already infected surgical site, defined as: ICD-codes indicating infection, Open fractures, Traumatic wounds, Vacuum assisted wound therapy
  • Patients that have had antibiotics prescribed 2 weeks or less prior to surgery
  • Patients that have actively marked their hospital charts with an added privacy notice

结局指标

主要结局

Number of patients with surgical site infection after orthopaedic surgery, defined as any of the following: using antibiotics targeting Staphylococcus aureus, having ICD-codes or surgery codes indicating postoperative infection.

时间窗: Within 12 weeks after surgery

All definitions are merged into one binary outcome measure as "any(No. \> 0)"

次要结局

  • Number of days with antibiotics(Two treatment days or more during the first 90 postoperative days)
  • Death(during the first 2 postoperative years)
  • Patients using any antibiotics after surgery(Two treatment days or more during the first 90 postoperative days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Max Gordon

M.D., PhD

Karolinska Institutet

研究点 (2)

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