Central venous access device Securement and dressing effectiveness: The CASCADE pilot randomised controlled trial in the adult intensive care.

INTRODUCTION: Central venous access devices (CVADs) are a vital medical device for intensive care (ICU) patients; however, complications and failure are common, yet potentially prevented through effective dressings and securement. OBJECTIVES/AIMS: The objective of this study was to test the feasibility of a randomised controlled trial (RCT) comparing standard care with three dressing and securement products to prevent CVAD failure. Secondary aims included comparing dressing and securement products on CVAD failure, microbial colonisation, and intervention costs. METHODS: A single-centre pilot RCT of ICU adult patients requiring CVADs for >24 h were randomised to four groups: (i) sutures plus chlorhexidine gluconate (CHG) dressing (standard care); (ii) standard care plus tissue adhesive (TA); (iii) two sutureless stabilisation devices (SSD) plus CHG dressing; (iv) sutures, CHG disc plus integrated securement dressing (ISD). Descriptive statistics assessed feasibility. Incidence rates (IRs) of CVAD failure were reported, with group differences compared using the Fisher exact and log-rank tests. Cox regression explored univariable risks for failure. A substudy examined bacterial colonisation of catheter tips, dressings, and skin. Cost estimates of the intervention were compared. RESULTS: A total of 121 participants were randomised. Study feasibility was established with no withdrawal and moderate staff acceptability; however, recruitment was low at 12%. Overall CVAD failure was seen in 14 of 114 (12%) CVADs (19 per 1000 catheter-days); highest in the SSD group (IR: 27.3 per 1000 catheter-days [95% confidence interval {CI}: 11.4-65.6]), followed by the standard care group (IR: 22.3 per 1000 catheter-days [95% CI: 8.38-59.5]) and TA group (IR: 20.6 per 1000 catheter-days [95% CI: 6.66-64.0]), and lowest in the ISD group (IR: 8.8 per 1000 catheter-days [95% CI: 2.19-35.0]). The majority of complications (11/14, 79%) were suspected central line-associated bloodstream infection (CLABSI), of which only one was laboratory confirmed (standard care group). The cost per patient was lowest in the standard care group by an average difference of AUD $14. CONCLUSION(S): A large multisite RCT examining forms of securement and dressing is feasible. ISD is the highest priority to test further as it had the lowest failure rate. TRIAL REGISTRATION: ACTRN12615000667516 PROTOCOL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 368765.

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

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.