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

• ClinicalTrials.gov Identifier: NCT02695368
• Recruitment Status: Completed
• First Posted: March 1, 2016
• Last Update Posted: June 24, 2022
• Sponsor: Karolinska Institutet
• Collaborator: The Swedish Research Council
• Information provided by (Responsible Party): Max Gordon, Karolinska Institutet

Tracking Information

• First Submitted Date: February 9, 2016
• First Posted Date: March 1, 2016
• Last Update Posted Date: June 24, 2022
• Actual Study Start Date: April 10, 2017
• Actual Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 22, 2018)

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)"

Original Primary Outcome Measures (submitted: February 24, 2016)

• Number of patients using antibiotics targeting Staphylococcus aureus [ Time Frame: 2 to 84 days after surgery ]
  All primary outcomes are merged into one binary outcome measure as "any(No. > 0)"
• Number of ICD-codes indicating postoperative infections [ Time Frame: Within 84 days after surgery ]
  All primary outcomes are merged into one binary outcome measure as "any(No. > 0)"
• Number of surgery codes indicating postoperative infections [ Time Frame: Within 84 days after surgery ]
  All primary outcomes are merged into one binary outcome measure as "any(No. > 0)"

Current Secondary Outcome Measures (submitted: January 22, 2018)

• 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.
• 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.
• 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.
• 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.
• Death [ Time Frame: during the first 2 postoperative years ]
  Any cause of death

Original Secondary Outcome Measures (submitted: February 24, 2016)

• 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.
• 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.
• 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.
• 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.
• Death [ Time Frame: during the first 2 postoperative years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Plasma-air-filtration on the Incidence of Surgical Site Infections in Orthopaedic Surgery
• 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
• 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).
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Orthopaedic Surgery (30 Minutes or Longer)

Intervention

• 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.
• Device: Novaerus NV800 off
  The machine decribed above is running but the plasma filter chamber isn't active, i.e. the placebo 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.

Study Arms

• 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
  Intervention: Device: Novaerus NV800 on
• Experimental: Unexposed patients: Plasma-filter off
  Those with Novaerus NV800 off for at least 2 Days prior to index surgery
  Intervention: Device: Novaerus NV800 off
• 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.
  Intervention: Device: Novaerus NV800 on or off

• Publications *: Persson A, Atroshi I, Tyszkiewicz T, Hailer N, Lazarinis S, Eisler T, Brismar H, Mukka S, Kernell PJ, Mohaddes M, Sköldenberg O, Gordon M. EPOS trial: the effect of air filtration through a plasma chamber on the incidence of surgical site infection in orthopaedic surgery: a study protocol of a randomised, double-blind, placebo-controlled trial. BMJ Open. 2022 Feb 3;12(2):e047500. doi: 10.1136/bmjopen-2020-047500.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 17, 2021): 45000
• Original Estimated Enrollment (submitted: February 24, 2016): 19000
• Actual Study Completion Date: December 31, 2021
• Actual Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT02695368
• Other Study ID Numbers: EPOS
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Max Gordon, Karolinska Institutet
• Original Responsible Party: Same as current
• Current Study Sponsor: Karolinska Institutet
• Original Study Sponsor: Same as current
• Collaborators: The Swedish Research Council

Investigators

• Principal Investigator: Max Gordon, M.D, PhD; Danderyd Hospital, Stockholm, Sweden

• PRS Account: Karolinska Institutet
• Verification Date: June 2022