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

Orthopaedic Surgery (30 Minutes or Longer) Clinical Trial

— EPOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695368
• Other study ID #: EPOS
• Status: Completed
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Orthopaedic Surgery (30 Minutes or Longer)
• Surgical Wound Infection

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

Locations

Country	Name	City	State
Sweden	Danderyds Sjukhus AB	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patients using any antibiotics after surgery	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.	Two treatment days or more during the first 30 postoperative days
Secondary	Number of days with antibiotics	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.	During the first 30 postoperative days
Secondary	Patients using any antibiotics after surgery	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.	Two treatment days or more during the first 90 postoperative days
Secondary	Number of days with antibiotics	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.	Two treatment days or more during the first 90 postoperative days
Secondary	Death	Any cause of death	during the first 2 postoperative years