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

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

NCT02695368

EPOS

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

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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