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

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ClinicalTrials.gov Identifier: NCT02695368
Recruitment Status : Recruiting
First Posted : March 1, 2016
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Max Gordon, Karolinska Institutet

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Orthopaedic Surgery (30 Minutes or Longer) Device: Novaerus NV800 on Device: Novaerus NV800 off Device: Novaerus NV800 on or off Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Device: 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.
Experimental: Unexposed patients: Plasma-filter off
Those with Novaerus NV800 off for at least 2 Days prior to index surgery
 Device: Novaerus NV800 off
The machine decribed above is running but the plasma filter chamber isn't active, i.e. the placebo group.
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695368


Contacts
Contact: Max Gordon, M.D., PhD +46 8 123 558 84 max.gordon@ki.se
Contact: Anders Persson, MD +46 8 123 580 76 anders.persson@sll.se

Locations
Sweden
Danderyds Sjukhus AB Recruiting
Stockholm, Sweden, 182 88
Contact: Anders Persson, MD         
Contact: Olof Sköldenberg, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Investigators
Principal Investigator: Max Gordon, M.D, PhD Danderyd Hospital, Stockholm, Sweden
More Information
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Responsible Party: Max Gordon, M.D., PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02695368     History of Changes
Other Study ID Numbers: EPOS
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes