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Completed

NCT Number: NCT02695368

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

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danderyds Sjukhus AB

Stockholm, 182 88, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novaerus NV800 on

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.

Novaerus NV800 off

Device

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

Novaerus NV800 on or off

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.

Primary outcomes

  1. 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.

    Time frame: Within 12 weeks after surgery

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

Secondary outcomes

  1. Patients using any antibiotics after surgery

    Time frame: Two treatment days or more during the first 30 postoperative days

    This is identified either via hospital information system or from the national drug registry. Usage is defined as withdrawal or prescription of a drug with ATC code within the J01 group.

  2. Number of days with antibiotics

    Time frame: During the first 30 postoperative days

    This is identified either via hospital information system or from the national drug registry. Usage is defined as withdrawal or prescription of a drug with ATC code within the J01 group. Number of days is deduced from the prescribed dosage or if not present the average daily dosage for that particular drug is used.

  3. Patients using any antibiotics after surgery

    Time frame: Two treatment days or more during the first 90 postoperative days

    This is identified either via hospital information system or from the national drug registry. Usage is defined as withdrawal or prescription of a drug with ATC code within the J01 group.

  4. Number of days with antibiotics

    Time frame: Two treatment days or more during the first 90 postoperative days

    This is identified either via hospital information system or from the national drug registry. Usage is defined as withdrawal or prescription of a drug with ATC code within the J01 group. Number of days is deduced from the prescribed dosage or if not present the average daily dosage for that particular drug is used.

  5. Death

    Time frame: during the first 2 postoperative years

    Any cause of death

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • The Swedish Research Council

Registry information

Official study title

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

Acronym: EPOS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2016
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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