Central venous access device securement and dressing effectiveness: the cascade pilot randomised controlled trial in adult intensive care

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Mitchell, Marion
Ullman, Amanda
Takashima, Mari
Davis, Chelsea
Mihala, Gabor
Powell, Madeleine
Gibson, Victoria
Zhang, Li
Bauer, Michelle
Playford, Geoffrey
Rickard, Claire
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Melbourne, Australia


Introduction: Central venous access devices (CVADs) are a vital medical device for intensive care (ICU) patients, however CVAD complications and failure are common, yet potentially prevented through effective dressings and securement. Objectives/Aims: 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: (i) sutures plus chlorhexidine gluconate (CHG) dressing (standard-care); (ii) standard-care plus tissue adhesive (TA); (iii) two sutureless-stabilisation-devices plus CHG dressing (SSD); (iv) sutures, CHG-disc plus integrated-securement-dressing (ISD). Descriptive statistics assessed feasibility. Incidence rates (IR) of CVAD failure compared group differences with Fisher’s exact and log-rank tests. Cox regression explored univariable risks for failure. A sub-study examined bacterial colonisation of catheter tips, dressings and skin. Cost estimates of the intervention were compared. Results: One-hundred and twenty-one participants were randomised. Study feasibility was established with no withdrawal and high staff acceptability of study interventions. Overall CVAD failure was 14/114 (12%) of CVADs (19 per 1000 catheter-days); highest in the SSD group (IR:27.3 per 1000 catheter-days [95% 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-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: A large multi-site RCT examining forms of securement and dressing is feasible. ISD is the highest priority to test further as it had the lowest failure rate.

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Australian Critical Care

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Mitchell, M; Ullman, A; Takashima, M; Davis, C; Mihala, G; Powell, M; Gibson, V; Zhang, L; Bauer, M; Playford, G; Rickard, C, Central venous access device securement and dressing effectiveness: the cascade pilot randomised controlled trial in adult intensive care, Australian Critical Care, 2020, 33, pp. S2-S2