The Effect of Plasma-air-filtration on the Incidence of Surgical Site Infections in Orthopaedic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2021-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Orthopaedic Surgery (30 Minutes or Longer)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Exposed patients: Plasma-filter on

Those operated with Novaerus NV800 on for at least 2 Days prior to index surgery. This Group will also in the analysis be sub-grouped according to measurements prior to study start into:

* regular operating theater
* ultra-Clean operating theaters

Group Type EXPERIMENTAL

Novaerus NV800 on

Intervention Type DEVICE

The air-cleaner 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 plasma and eradicates any bacteria that pass through. The air-cleaner has to have been turned on for at least 2 days prior to the surgical intervention.

Unexposed patients: Plasma-filter off

Those with Novaerus NV800 off for at least 2 Days prior to index surgery

Group Type EXPERIMENTAL

Novaerus NV800 off

Intervention Type DEVICE

The machine decribed above is running but the plasma filter chamber isn't active, i.e. the placebo group.

Mixed patients: Plasma-filter on or off

Those receiving multiple surgeries in different theaters with Novaerus NV800 on or off status will belong to a mixed Group.

Group Type EXPERIMENTAL

Novaerus NV800 on or off

Intervention Type DEVICE

Patients with multiple surgeries that have been operated during both periods when the apparatus has been on and off will belong to this mixed group.

Interventions

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Novaerus NV800 on

The air-cleaner 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 plasma and eradicates any bacteria that pass through. The air-cleaner has to have been turned on for at least 2 days prior to the surgical intervention.

Intervention Type DEVICE

Novaerus NV800 off

The machine decribed above is running but the plasma filter chamber isn't active, i.e. the placebo group.

Intervention Type DEVICE

Novaerus NV800 on or off

Patients with multiple surgeries that have been operated during both periods when the apparatus has been on and off will belong to this mixed group.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No