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

Not Applicable

Completed

Interventions: Device: Novaerus NV800 on
Device: Novaerus NV800 on or off
Device: Novaerus NV800 off

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Exposed patients: Plasma-filter on	Novaerus NV800 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
Mixed patients: Plasma-filter on or off	Novaerus NV800 on or off	Those receiving multiple surgeries in different theaters with Novaerus NV800 on or off status will belong to a mixed Group.
Unexposed patients: Plasma-filter off	Novaerus NV800 off	Those with Novaerus NV800 off for at least 2 Days prior to index surgery

Primary Outcome Measures

Name	Time	Method
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.	Within 12 weeks after surgery	All definitions are merged into one binary outcome measure as "any(No. \> 0)"

Secondary Outcome Measures

Name	Time	Method
Number of days with antibiotics	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	during the first 2 postoperative years	Any cause of death
Patients using any antibiotics after surgery	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.