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

NCT02695368 | Completed

• 1 other identifier: EPOS
• Study Type: interventional
• Target: 45,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Orthopaedic Surgery (30 Minutes or Longer)

Outcome Measures

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.

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

  Within 12 weeks after surgery

Secondary Outcomes (5)

• Patients using any antibiotics after surgery

  Two treatment days or more during the first 30 postoperative days

• Number of days with antibiotics

  During the first 30 postoperative days

• Patients using any antibiotics after surgery

  Two treatment days or more during the first 90 postoperative days

• Number of days with antibiotics

  Two treatment days or more during the first 90 postoperative days

• Death

  during the first 2 postoperative years

Study Arms (3)

Exposed patients: Plasma-filter on

EXPERIMENTAL

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

Unexposed patients: Plasma-filter off

EXPERIMENTAL

Those with Novaerus NV800 off for at least 2 Days prior to index surgery

Device: Novaerus NV800 off

Mixed patients: Plasma-filter on or off

EXPERIMENTAL

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

Interventions

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.

Exposed patients: Plasma-filter on

Novaerus NV800 off DEVICE

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

Unexposed patients: Plasma-filter off

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.

Mixed patients: Plasma-filter on or off

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients that undergo a 30 minute or longer orthopaedic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Danderyds Sjukhus AB

Stockholm, 182 88, Sweden

Location

Related Publications (2)

• Persson A, Atroshi I, Tyszkiewicz T, Hailer NP, Lazarinis S, Eisler T, Brismar H, Mukka S, Kernell PJ, Mohaddes M, Skoldenberg O, Gordon M. Effect of Plasma Air Purifiers on Infection Rates in Orthopedic Surgery. NEJM Evid. 2025 Apr;4(4):EVIDoa2400289. doi: 10.1056/EVIDoa2400289. Epub 2025 Mar 25.

  PMID: 40130977 DERIVED

• Persson A, Atroshi I, Tyszkiewicz T, Hailer N, Lazarinis S, Eisler T, Brismar H, Mukka S, Kernell PJ, Mohaddes M, Skoldenberg 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.

  PMID: 35115346 DERIVED

Study Officials

• Max Gordon, M.D, PhD

  Danderyd Hospital, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: March 1, 2016
• Study Start: April 10, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)