TY - JOUR
T1 - Peripherally InSerted CEntral catheter dressing and securement in patients with cancer
T2 - The PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial
AU - Rickard, Claire M.
AU - Marsh, Nicole M.
AU - Webster, Joan
AU - Gavin, Nicole C.
AU - Chan, Raymond J.
AU - McCarthy, Alexandra L.
AU - Mollee, Peter
AU - Ullman, Amanda J.
AU - Kleidon, Tricia
AU - Chopra, Vineet
AU - Zhang, Li
AU - McGrail, Matthew R.
AU - Larsen, Emily
AU - Choudhury, Md Abu
AU - Keogh, Samantha
AU - Alexandrou, Evan
AU - McMillan, David J.
AU - Mervin, Merehau Cindy
AU - Paterson, David L.
AU - Cooke, Marie
AU - Ray-Barruel, Gillian
AU - Castillo, Maria Isabel
AU - Hallahan, Andrew
AU - Corley, Amanda
AU - Geoffrey Playford, E.
N1 - Publisher Copyright:
© Article author(s).
PY - 2017/6/1
Y1 - 2017/6/1
N2 - 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.
AB - 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.
KW - Catheter obstruction
KW - Catheter-related infections
KW - Catheterization, Central Venous
KW - Occlusive dressings.
KW - Upper extremity deep vein thrombosis
UR - http://www.scopus.com/inward/record.url?scp=85020898264&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2016-015291
DO - 10.1136/bmjopen-2016-015291
M3 - Article
C2 - 28619777
AN - SCOPUS:85020898264
SN - 2044-6055
VL - 7
SP - 1
EP - 8
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e015291
ER -