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

• Introduction There is controversy regarding the importance of air-transmitted infections for surgical site infections (SSIs) after orthopaedic surgery. Research has been hindered by both the inability in blinding the exposure, and by the need for recruiting large enough cohorts. The aim of this study is to investigate whether using a new form of air purifier using plasma air purification (PAP) in operating rooms (ORs) lowers the SSI rate or not. Methods and analysis Multicentre, double-blind, cluster-randomised, placebo-controlled trial conducted at seven hospitals in 2017-2022. All patients that undergo orthopaedic surgery for minimum 30 min are included. Intervention group: patients operated in OR with PAP devices turned on. Control group: patients operated in OR with PAP devices turned off. Randomisation: each OR will be randomised in periods of 4 weeks, 6 weeks or 8 weeks to either have the devices on or off. Primary outcome: any SSI postoperatively defined as a composite endpoint of any of the following: use of isoxazolylpenicillin, clindamycin or rifampicin for 2 days or more, International Classification of Diseases codes or Nordic Medico-Statistical Committee codes indicating postoperative infection. In a second step, we will perform a chart review on those patients with positive indicators of SSI to further validate the outcome. Secondary outcomes are described in the Methods section. Power: we assume an SSI rate of 2%, an SSI reduction rate of 25% and we need approximately 45 000 patients to attain a power of 80% at a significance level of 0.05. Ethics and dissemination The study is approved by the Swedish Ethical Review Authority. The interim analysis results from the study will be presented only to the researchers involved unless the study thereafter is interrupted for whatever reason. Publication in a medical journal will be presented after inclusion of the last patient. Trial registration number NCT02695368. © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kirurgi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Surgery (hsv//eng)

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Infektionsmedicin (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Infectious Medicine (hsv//eng)

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Ortopedi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Orthopaedics (hsv//eng)

Nyckelord

adult orthopaedics

hip

infection control

knee

orthopaedic & trauma surgery

clindamycin

isoxazolylpenicillin

penicillin derivative

rifampicin

unclassified drug

adult

air and air related phenomena

air conditioning

airborne infection

airborne transmission

Article

clinical article

clinical trial protocol

controlled study

double blind procedure

female

hospital readmission

human

incidence

infection rate

International Classification of Diseases

length of stay

male

multicenter study

orthopedic surgery

plasma air purification

prescription

randomized controlled trial

reoperation

room ventilation

surgical infection

Sweden

total hip replacement

adult orthopaedics

Surgery

Orthopaedics

Publikations- och innehållstyp

ref (ämneskategori)

art (ämneskategori)