Journal article
Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial
BMJ Open, Vol.7(6), e015291
2017
Abstract
Introduction Around 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure. Methods and analysis Pragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED. Secondary outcomes: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant.
Details
- Title
- Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial
- Authors
- Claire M Rickard (Author) - Griffith UniversityNicole M Marsh (Author) - Griffith UniversityJoan Webster (Author) - Griffith UniversityNicole C Gavin (Author) - Griffith UniversityRaymond J Chan (Author) - Griffith UniversityAlexandra L McCarthy (Author) - Griffith UniversityPeter Mollee (Author) - Griffith UniversityAmanda J Ullman (Author) - Griffith UniversityTricia Kleidon (Author) - Griffith UniversityVineet Chopra (Author) - Griffith UniversityLi Zhang (Author) - Griffith UniversityMatthew R McGrail (Author) - Griffith UniversityEmily Larsen (Author) - Griffith UniversityMd Abu Choudhury (Author) - Griffith UniversitySamantha Keogh (Author) - Griffith UniversityEvan Alexandrou (Author) - Griffith UniversityDavid J McMillan (Author) - University of the Sunshine Coast - Faculty of Science, Health, Education and EngineeringMerehau Cindy Mervin (Author) - Griffith UniversityDavid L Paterson (Author) - Griffith UniversityMarie Cooke (Author) - Griffith UniversityGillian Ray-Barruel (Author) - Griffith UniversityMaria Isabel Castillo (Author) - Griffith UniversityAndrew Hallahan (Author) - Griffith UniversityAmanda Corley (Author) - Griffith UniversityE Geoffrey Playford (Author) - Griffith University
- Publication details
- BMJ Open, Vol.7(6), e015291; 8
- Publisher
- B M J Group
- Date published
- 2017
- DOI
- 10.1136/bmjopen-2016-015291
- ISSN
- 2044-6055
- Copyright note
- Copyright © 2017 The Authors. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
- Organisation Unit
- University of the Sunshine Coast, Queensland; School of Health and Sport Sciences - Legacy; School of Science, Technology and Engineering; Centre for Bioinnovation
- Language
- English
- Record Identifier
- 99451168702621
- Output Type
- Journal article
Metrics
58 File views/ downloads
1284 Record Views
InCites Highlights
These are selected metrics from InCites Benchmarking & Analytics tool, related to this output
- Collaboration types
- Domestic collaboration
- International collaboration
- Web Of Science research areas
- Infectious Diseases
UN Sustainable Development Goals (SDGs)
This output has contributed to the advancement of the following goals:
Source: InCites