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
(2022) In BMJ Open 12(2).- Abstract
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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2022-02
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- adult orthopaedics, hip, infection control, knee, orthopaedic & trauma surgery
- in
- BMJ Open
- volume
- 12
- issue
- 2
- article number
- 047500
- publisher
- BMJ Publishing Group
- external identifiers
-
- pmid:35115346
- scopus:85123974770
- ISSN
- 2044-6055
- DOI
- 10.1136/bmjopen-2020-047500
- language
- English
- LU publication?
- yes
- id
- 6046ccd9-3112-4670-9239-df79ea0671cf
- date added to LUP
- 2022-04-07 12:22:19
- date last changed
- 2024-06-21 10:08:09
@article{6046ccd9-3112-4670-9239-df79ea0671cf,
abstract = {{<p>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. </p>}},
author = {{Persson, Anders and Atroshi, Isam and Tyszkiewicz, Thomas and Hailer, Nils and Lazarinis, Stergios and Eisler, Thomas and Brismar, Harald and Mukka, Sebastian and Kernell, Per Juan and Mohaddes, Maziar and Sköldenberg, Olof and Gordon, Max}},
issn = {{2044-6055}},
keywords = {{adult orthopaedics; hip; infection control; knee; orthopaedic & trauma surgery}},
language = {{eng}},
number = {{2}},
publisher = {{BMJ Publishing Group}},
series = {{BMJ Open}},
title = {{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}},
url = {{http://dx.doi.org/10.1136/bmjopen-2020-047500}},
doi = {{10.1136/bmjopen-2020-047500}},
volume = {{12}},
year = {{2022}},
}