Dataset Information

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

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.

SUBMITTER: Rickard CM

PROVIDER: S-EPMC5734285 | biostudies-other | 2017 Jun

REPOSITORIES: biostudies-other

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

Rickard Claire M CM Marsh Nicole M NM Webster Joan J Gavin Nicole C NC Chan Raymond J RJ McCarthy Alexandra L AL Mollee Peter P Ullman Amanda J AJ Kleidon Tricia T Chopra Vineet V Zhang Li L McGrail Matthew R MR Larsen Emily E Choudhury Md Abu MA Keogh Samantha S Alexandrou Evan E McMillan David J DJ Mervin Merehau Cindy MC Paterson David L DL Cooke Marie M Ray-Barruel Gillian G Castillo Maria Isabel MI Hallahan Andrew A Corley Amanda A Geoffrey Playford E E

BMJ open 20170615 6

<h4>Introduction</h4>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 ...[more]

PMID: 28619777

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Project description:OBJECTIVES:To assess the effect on needed nursing time for dressing change. DESIGN, SETTING, PARTICIPANTS:A parallel-group, open-label, randomised controlled trial in patients who are in need for a peripherally inserted central catheter insertion in one teaching hospital in Belgium. The follow-up lasted 180 days or until catheter removal, whatever came first. A computer generated table was used to allocate devices. Randomised patients were 105 adults (StatLock, n=53; SecurAcath, n=52) and primary analysis was based on all patients (n=92) with time measurements (StatLock, n=43; SecurAcath, n=49). INTERVENTIONS:StatLock which has to be changed weekly versus SecurAcath which could remain in place for the complete catheter dwell time. MAIN OUTCOME MEASURE:Needed time for the dressing change at each dressing change (SecurAcath) or at each dressing change combined with the change of the securement device (StatLock). RESULTS:Median time needed for dressing change was 7.3?min (95%?CI 6.4?min to 8.3?min) in the StatLock group and in the SecurAcath group 4.3?min (95%?CI 3.8 min to 4.9?min) (P<0.0001). The time in the SecurAcath group was reduced with 41% (95% CI 29% to 51%). Incidence rates of migration, dislodgement and catheter-related bloodstream infection were comparable across groups. Pain scores were higher with SecurAcath than with StatLock at insertion (P=0.02) and at removal (P<0.001) and comparable during dressing change (P=0.38) and during dwell time (P=0.995). User-friendliness was scored at insertion and removal. All statements regarding the user-friendliness were scored significantly higher for StatLock than for SecurAcath (P<0.05). Only for the statement regarding the recommending routine use of the device, which was asked at removal, no difference was found between the two devices (P=0.32). CONCLUSION:Use of SecurAcath saves time during dressing change compared with StatLock. Training on correct placement and removal of SecurAcath is critical to minimise pain. TRIAL REGISTRATION NUMBER:NCT02311127; Pre-results.

Dataset Information

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

Publications

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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