Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial

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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.

Ethics and dissemination

Ethical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published.

Trial registration

Trial registration number is: ACTRN12616000315415.

Related collections

Most cited references 40

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Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta-analysis.

Vineet Chopra, Sarah Anand, Andy Hickner … (2013)

Peripherally inserted central catheters (PICCs) are associated with an increased risk of venous thromboembolism. However, the size of this risk relative to that associated with other central venous catheters (CVCs) is unknown. We did a systematic review and meta-analysis to compare the risk of venous thromboembolism associated with PICCs versus that associated with other CVCs. We searched several databases, including Medline, Embase, Biosis, Cochrane Central Register of Controlled Trials, Conference Papers Index, and Scopus. Additional studies were identified through hand searches of bibliographies and internet searches, and we contacted study authors to obtain unpublished data. All human studies published in full text, abstract, or poster form were eligible for inclusion. All studies were of adult patients aged at least 18 years who underwent insertion of a PICC. Studies were assessed with the Newcastle-Ottawa risk of bias scale. In studies without a comparison group, the pooled frequency of venous thromboembolism was calculated for patients receiving PICCs. In studies comparing PICCs with other CVCs, summary odds ratios (ORs) were calculated with a random effects meta-analysis. Of the 533 citations identified, 64 studies (12 with a comparison group and 52 without) including 29 503 patients met the eligibility criteria. In the non-comparison studies, the weighted frequency of PICC-related deep vein thrombosis was highest in patients who were critically ill (13·91%, 95% CI 7·68-20·14) and those with cancer (6·67%, 4·69-8·64). Our meta-analysis of 11 studies comparing the risk of deep vein thrombosis related to PICCs with that related to CVCs showed that PICCs were associated with an increased risk of deep vein thrombosis (OR 2·55, 1·54-4·23, p<0·0001) but not pulmonary embolism (no events). With the baseline PICC-related deep vein thrombosis rate of 2·7% and pooled OR of 2·55, the number needed to harm relative to CVCs was 26 (95% CI 13-71). PICCs are associated with a higher risk of deep vein thrombosis than are CVCs, especially in patients who are critically ill or those with a malignancy. The decision to insert PICCs should be guided by weighing of the risk of thrombosis against the benefit provided by these devices. None. Copyright © 2013 Elsevier Ltd. All rights reserved.

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Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial.

Sébastian Pease, Carole Schwebel, Xavier Arrault … (2009)

Use of a chlorhexidine gluconate-impregnated sponge (CHGIS) in intravascular catheter dressings may reduce catheter-related infections (CRIs). Changing catheter dressings every 3 days may be more frequent than necessary. To assess superiority of CHGIS dressings regarding the rate of major CRIs (clinical sepsis with or without bloodstream infection) and noninferiority (less than 3% colonization-rate increase) of 7-day vs 3-day dressing changes. Assessor-blind, 2 x 2 factorial, randomized controlled trial conducted from December 2006 through June 2008 and recruiting patients from 7 intensive care units in 3 university and 2 general hospitals in France. Patients were adults (>18 years) expected to require an arterial catheter, central-vein catheter, or both inserted for 48 hours or longer. Use of CHGIS vs standard dressings (controls). Scheduled change of unsoiled adherent dressings every 3 vs every 7 days, with immediate change of any soiled or leaking dressings. Major CRIs for comparison of CHGIS vs control dressings; colonization rate for comparison of 3- vs 7-day dressing changes. Of 2095 eligible patients, 1636 (3778 catheters, 28,931 catheter-days) could be evaluated. The median duration of catheter insertion was 6 (interquartile range [IQR], 4-10) days. There was no interaction between the interventions. Use of CHGIS dressings decreased the rates of major CRIs (10/1953 [0.5%], 0.6 per 1000 catheter-days vs 19/1825 [1.1%], 1.4 per 1000 catheter-days; hazard ratio [HR], 0.39 [95% confidence interval {CI}, 0.17-0.93]; P = .03) and catheter-related bloodstream infections (6/1953 catheters, 0.40 per 1000 catheter-days vs 17/1825 catheters, 1.3 per 1000 catheter-days; HR, 0.24 [95% CI, 0.09-0.65]). Use of CHGIS dressings was not associated with greater resistance of bacteria in skin samples at catheter removal. Severe CHGIS-associated contact dermatitis occurred in 8 patients (5.3 per 1000 catheters). Use of CHGIS dressings prevented 1 major CRI per 117 catheters. Catheter colonization rates were 142 of 1657 catheters (7.8%) in the 3-day group (10.4 per 1000 catheter-days) and 168 of 1828 catheters (8.6%) in the 7-day group (11.0 per 1000 catheter-days), a mean absolute difference of 0.8% (95% CI, -1.78% to 2.15%) (HR, 0.99; 95% CI, 0.77-1.28), indicating noninferiority of 7-day changes. The median number of dressing changes per catheter was 4 (IQR, 3-6) in the 3-day group and 3 (IQR, 2-5) in the 7-day group (P < .001). Use of CHGIS dressings with intravascular catheters in the intensive care unit reduced risk of infection even when background infection rates were low. Reducing the frequency of changing unsoiled adherent dressings from every 3 days to every 7 days modestly reduces the total number of dressing changes and appears safe. clinicaltrials.gov Identifier: NCT00417235.

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The risk of bloodstream infection associated with peripherally inserted central catheters compared with central venous catheters in adults: a systematic review and meta-analysis.

Ian Rogers, Nasia Safdar, John O'Horo … (2013)

Peripherally inserted central catheters (PICCs) are associated with central line-associated bloodstream infection (CLABSI). The magnitude of this risk relative to central venous catheters (CVCs) is unknown. To compare risk of CLABSI between PICCs and CVCs. MEDLINE, CinAHL, Scopus, EmBASE, and Cochrane CENTRAL were searched. Full-text studies comparing the risk of CLABSI between PICCs and CVCs were included. Studies involving adults 18 years of age or older who underwent insertion of a PICC or a CVC and reported CLABSI were included in our analysis. Studies were evaluated using the Downs and Black scale for risk of bias. Random effects meta-analyses were used to generate summary estimates of CLABSI risk in patients with PICCs versus CVCs. Of 1,185 studies identified, 23 studies involving 57,250 patients met eligibility criteria. Twenty of 23 eligible studies reported the total number of CLABSI episodes in patients with PICCs and CVCs. Pooled meta-analyses of these studies revealed that PICCs were associated with a lower risk of CLABSI than were CVCs (relative risk [RR], 0.62; 95% confidence interval [CI], 0.40-0.94). Statistical heterogeneity prompted subgroup analysis, which demonstrated that CLABSI reduction was greatest in outpatients (RR [95% CI], 0.22 [0.18-0.27]) compared with hospitalized patients who received PICCs (RR [95% CI], 0.73 [0.54-0.98]). Thirteen of the included 23 studies reported CLABSI per catheter-day. Within these studies, PICC-related CLABSI occurred as frequently as CLABSI from CVCs (incidence rate ratio [95% CI], 0.91 [0.46-1.79]). Only 1 randomized trial met inclusion criteria. CLABSI definition and infection prevention strategies were variably reported. Few studies reported infections by catheter-days. Although PICCs are associated with a lower risk of CLABSI than CVCs in outpatients, hospitalized patients may be just as likely to experience CLABSI with PICCs as with CVCs. Consideration of risks and benefits before PICC use in inpatient settings is warranted.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Open (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2017

Publication date (Electronic): 15 June 2017

Volume: 7

Issue: 6

Electronic Location Identifier: e015291

Affiliations

[1 ] departmentAlliance for Vascular Access Teaching and Research (AVATAR) , Menzies Health Institute Queensland, Griffith University , Brisbane, Australia

[2 ] Royal Brisbane and Women’s Hospitals , Brisbane, Australia

[3 ] Princess Alexandra Hospital , Brisbane, Australia

[4 ] departmentSchool of Nursing , Institute of Health and Biomedical Innovation, Queensland University of Technology , Brisbane, Australia

[5 ] departmentSchool of Nursing , University of Auckland , Auckland, New Zealand

[6 ] departmentSchool of Medicine , University of Queensland , Brisbane, Australia

[7 ] Lady Cilento Children’s Hospital , Brisbane, Australia

[8 ] departmentPatient Safety Enhancement Program , University of Michigan Health System and VA Ann Arbor Health System , Ann Arbor, Michigan, USA

[9 ] departmentSchool of Rural Health , Monash University , Churchill, Australia

[10 ] departmentUniversity of Queensland Centre for Clinical Research , Royal Brisbane and Women's Hospital Campus , Brisbane, Australia

[11 ] Western Sydney University and Liverpool Hospital , Sydney, Australia

[12 ] departmentInflammation and Healing Research Cluster , School of Health and Sport Sciences, University of the Sunshine Coast , Maroochydore, Australia

[13 ] departmentCentre for Applied Health Economics , School of Medicine, Menzies Health Institute Queensland, Griffith University , Brisbane, Australia

[14 ] departmentCentre for Clinical Research , University of Queensland , Brisbane, Australia

Author notes

[Correspondence to ] professor Claire M Rickard; c.rickard@ 123456griffith.edu.au

Article

Publisher ID: bmjopen-2016-015291

DOI: 10.1136/bmjopen-2016-015291

PMC ID: 5734285

PubMed ID: 28619777

SO-VID: 9bf72550-5f06-46d0-8865-47005c38ad21

License:

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/

History

Date received : 01 December 2016

Date revision received : 23 March 2017

Date accepted : 31 March 2017

Funding

Funded by: Princess Alexandra Hospital;

Funded by: FundRef http://dx.doi.org/10.13039/501100001791, Griffith University;

Funded by: Royal Brisbane and Women's Hospital;

Funded by: Lady Cilento Children's Hospital;

Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;

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special-feature unlocked

ScienceOpen disciplines: Medicine

Keywords: catheterization, central venous,upper extremity deep vein thrombosis,catheter-related infections,catheter obstruction,occlusive dressings.

Data availability:

ScienceOpen disciplines: Medicine

Keywords: catheterization, central venous, upper extremity deep vein thrombosis, catheter-related infections, catheter obstruction, occlusive dressings.

Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration

Related collections

Herbal Medicines Journal (Herb Med J)

Most cited references 40

Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta-analysis.

Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial.

The risk of bloodstream infection associated with peripherally inserted central catheters compared with central venous catheters in adults: a systematic review and meta-analysis.

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