A novel integrated dressing to secure peripheral intravenous catheters in an adult acute hospital: a pilot randomised controlled trial

Background The reported incidence of peripheral intravenous catheter (PIV) failure has been as high as 69%. This is in part due to inadequate stabilisation or securement to the skin, which allows micro-motion of the catheter within the vein. Methods A pilot open randomised controlled trial of 300 patients was conducted in the medical and surgical wards of a large tertiary hospital. A superiority parallel pragmatic design was used. Eligible patients over the age of 16 years were randomised using a centralised service (randomly varied block sizes and 1:1 ratio) to have PIV dressings of either (i) a bordered polyurethane dressing (BPU, standard care) or (ii) the integrated securement device (ISD). Allocation was concealed until entry. The primary outcome of feasibility addressed eligibility, consent, protocol adherence and retention rates. All-cause PIV failure was an additional primary outcome. This was a composite of infection (laboratory-confirmed local or bloodstream infection), occlusion or infiltration, dislodgement, phlebitis and thrombosis. Group comparisons were by proportions, incidence rates per 1000 PIV days and hazard ratios. Secondary outcomes were local or bloodstream infection, occlusion or infiltration, dislodgement, phlebitis, thrombosis, PIV dwell time, safety and adverse events and patient satisfaction with study products. Analysis was by intention to treat and the patient was the unit of measurement. Multivariable modelling was undertaken. Results Feasibility outcomes were 91% of screened patients were eligible, 98% of invited patients consented, 100% of randomised participants received the allocated intervention on insertion and 1/300 (