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 :
Completed
First Posted : March 1, 2016
Last Update Posted : June 24, 2022
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Condition or disease | Intervention/treatment | Phase |
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Orthopaedic Surgery (30 Minutes or Longer) | Device: Novaerus NV800 on Device: Novaerus NV800 off Device: Novaerus NV800 on or off | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45000 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 |
Actual Primary Completion Date : | December 31, 2021 |
Actual Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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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:
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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
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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.
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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. |
- 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)"
- 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

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

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
Sweden | |
Danderyds Sjukhus AB | |
Stockholm, Sweden, 182 88 |
Principal Investigator: | Max Gordon, M.D, PhD | Danderyd Hospital, Stockholm, Sweden |
Responsible Party: | Max Gordon, M.D., PhD, Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT02695368 |
Other Study ID Numbers: |
EPOS |
First Posted: | March 1, 2016 Key Record Dates |
Last Update Posted: | June 24, 2022 |
Last Verified: | June 2022 |
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 |
Surgical Wound Infection Infections Wound Infection Postoperative Complications Pathologic Processes |