Orthopaedic Surgery (30 Minutes or Longer)
Conditions
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.
Interventions
DEVICENovaerus 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.
DEVICENovaerus NV800 off
The machine decribed above is running but the plasma filter chamber isn't active, i.e. the placebo group.
DEVICENovaerus 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.
Sponsors
The Swedish Research Council
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patients using any antibiotics after surgery | 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 | 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. |
| Death | during the first 2 postoperative years | Any cause of death |
Countries
Sweden
Outcome results
None listed