Clinical trial NCT02695368: The Effect of Plasma-air-filtration on the Incidence of Surgical Site Infections in Orthopaedic Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopaedic Surgery (30 Minutes or Longer)
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2016-03-01
Enrollment: 45000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Within 12 weeks after surgery
Secondary outcomes:
measure: Patients using any antibiotics after surgery
timeFrame: Two treatment days or more during the first 30 postoperative days
measure: Number of days with antibiotics
timeFrame: During the first 30 postoperative days
measure: Patients using any antibiotics after surgery
timeFrame: Two treatment days or more during the first 90 postoperative days
measure: Number of days with antibiotics
timeFrame: Two treatment days or more during the first 90 postoperative days
measure: Death
timeFrame: during the first 2 postoperative years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus AB
Study officials:
affiliation: Danderyd Hospital, Stockholm, Sweden
name: Max Gordon, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.