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dc.contributor.authorUllman, Amanda J
dc.contributor.authorAugust, Deanne
dc.contributor.authorKleidon, Tricia
dc.contributor.authorWalker, Rachel
dc.contributor.authorMarsh, Nicole M
dc.contributor.authorBulmer, Andrew
dc.contributor.authorPearch, Benjamin
dc.contributor.authorSchults, Jessica A
dc.contributor.authorLeema, Joanne
dc.contributor.authorGibson, Victoria
dc.contributor.authorByrnes, Joshua
dc.contributor.authorWare, Robert S
dc.contributor.authorChopra, Vineet
dc.contributor.authorRickard, Claire M
dc.date.accessioned2021-04-23T00:58:21Z
dc.date.available2021-04-23T00:58:21Z
dc.date.issued2021
dc.identifier.issn2044-6055
dc.identifier.doi10.1136/bmjopen-2020-042475
dc.identifier.urihttp://hdl.handle.net/10072/403926
dc.description.abstractINTRODUCTION: Peripherally inserted central catheters (PICCs) are vital for the delivery of medical therapies, but up to 30% of PICCs are associated with complications such as deep vein thrombosis or infection. The integration of antimicrobial and hydrophobic catheter materials, and pressure-activated valves, into polyurethane PICCs are innovations designed to prevent infective and/or thrombotic complications. METHODS AND ANALYSIS: A multicentre, parallel group, superiority randomised controlled trial with two experimental arms ((1) hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp)). Recruitment of 1098 adult and paediatric patients will take place over 2 years at three tertiary-referral hospitals in Queensland, Australia. Patients are eligible for inclusion if their PICC is to be inserted for medical treatment, with a vascular size sufficient to support a 4-Fr PICC or larger, and with informed consent. The primary outcome is PICC failure, a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection). Secondary outcomes include: all-cause PICC complication; thrombotic complications; infective complications; adverse events (local or systemic reaction); PICC dwell time; patient/parent satisfaction; and healthcare costs. Differences between both intervention groups and the control group will be compared using Cox proportional hazards regression. Effect estimates will be presented as HRs with corresponding 95% CI. ETHICS AND DISSEMINATION: Ethical approval from Queensland Health (HREC/QCHQ/48682) and Griffith University (Ref. No. 2019/094). Results will be published. TRIAL REGISTRATION NUMBER: ACTRN12619000022167.
dc.description.peerreviewedYes
dc.languageeng
dc.publisherBMJ
dc.relation.ispartofpagefrome042475
dc.relation.ispartofissue4
dc.relation.ispartofjournalBMJ Open
dc.relation.ispartofvolume11
dc.subject.fieldofresearchClinical Sciences
dc.subject.fieldofresearchPublic Health and Health Services
dc.subject.fieldofresearchOther Medical and Health Sciences
dc.subject.fieldofresearchcode1103
dc.subject.fieldofresearchcode1117
dc.subject.fieldofresearchcode1199
dc.subject.keywordsinfection control
dc.subject.keywordsinterventional radiology
dc.subject.keywordsmicrobiology
dc.subject.keywordsthromboembolism
dc.subject.keywordsvascular medicine
dc.titlePeripherally Inserted Central catheter iNnovation to reduce Infections and Clots (the PICNIC trial): a randomised controlled trial protocol.
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationUllman, AJ; August, D; Kleidon, T; Walker, R; Marsh, NM; Bulmer, A; Pearch, B; Schults, JA; Leema, J; Gibson, V; Byrnes, J; Ware, RS; Chopra, V; Rickard, CM; et a., Peripherally Inserted Central catheter iNnovation to reduce Infections and Clots (the PICNIC trial): a randomised controlled trial protocol., BMJ Open, 2021, 11 (4), pp. e042475
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2021-04-23T00:22:32Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© Author(s) (or their employer(s)) 2021. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License, which permits unrestricted, non-commercial use, distribution and reproduction in any medium, providing that the work is properly cited.
gro.hasfulltextFull Text
gro.griffith.authorWare, Robert
gro.griffith.authorKleidon, Tricia
gro.griffith.authorLeema, Joanne
gro.griffith.authorByrnes, Joshua M.
gro.griffith.authorUllman, Amanda J.
gro.griffith.authorSchults, Jessica
gro.griffith.authorAugust, Deanne
gro.griffith.authorWalker, Rachel M.
gro.griffith.authorMarsh, Nicole M.
gro.griffith.authorBulmer, Andrew C.
gro.griffith.authorGibson, Victoria
gro.griffith.authorChopra, Vineet
gro.griffith.authorRickard, Claire


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