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

Karolinska Institute logo

Karolinska Institute

Status

Completed

Conditions

Orthopaedic Surgery (30 Minutes or Longer)

Treatments

Device: Novaerus NV800 on
Device: Novaerus NV800 on or off
Device: Novaerus NV800 off

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full description

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.

Enrollment

45,000 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

45,000 participants in 3 patient groups

Exposed patients: Plasma-filter on
Experimental group
Description:
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
Treatment:
Device: Novaerus NV800 on
Unexposed patients: Plasma-filter off
Experimental group
Description:
Those with Novaerus NV800 off for at least 2 Days prior to index surgery
Treatment:
Device: Novaerus NV800 off
Mixed patients: Plasma-filter on or off
Experimental group
Description:
Those receiving multiple surgeries in different theaters with Novaerus NV800 on or off status will belong to a mixed Group.
Treatment:
Device: Novaerus NV800 on or off

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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