Claire Rickard1,2, 3, Nicole Marsh1,2, Joan Webster1,2, Naomi Runnegar1,3, Emily Larsen1,2, Fiona Fullerton1,3, Md Abu Choudhury1, E Geoffrey Playford1,3.
1 Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, and School of Nursing and Midwifery, Griffith University, 170 Kessels Road, Nathan, QLD 4111, email@example.com
2 Royal Brisbane and Women’s Hospital, Bowen Bridge Road, Herston, QLD 4006.
3 Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102.
BACKGROUND: Two billion peripheral intravenous catheters (PIVCs) are used globally each year, but optimal dressing and securement methods are not well established. We compared three alternative approaches to standard non-bordered polyurethane dressings.
METHODS: Pragmatic, open, parallel, superiority, randomised controlled trial in two hospitals. Adults (≥18 years) with PIVCs of expected use >24 hours were randomly assigned (1:1:1:1) to (i) Tissue Adhesive with Polyurethane dressing, (ii) Bordered Polyurethane dressing, (iii) Securement Device with Polyurethane dressing, or (iv) Polyurethane dressing (controls). Randomisation was centralised, computer-generated, stratified, with concealed allocation. The primary outcome was PIVC failure (composite of dislodgement, occlusion, phlebitis, primary bloodstream, local infection). Participants and clinicians were not masked but infections were blind-adjudicated. Analysis was intention to treat. Trial registration: ACTRN12611000769987.
FINDINGS: Of 1807 randomised patients, 1697 (94%) had the primary endpoint available. PIVC failure was: 163/427 (38%) Tissue Adhesive with Polyurethane (absolute risk difference [ARD] -4∙5%, 95% CI -11∙1–2∙1%, p=0∙19); 169/423 (40%) Bordered Polyurethane (ARD -2∙7%, 95% CI -9∙3%–3∙9%, p=0∙44); 176/425 (41%) Securement Device with Polyurethane (ARD -1∙2%, 95% CI -7∙9%–5∙4%, p=0∙73); and 180/422 (43%) Polyurethane controls. There were three primary bloodstream infections (3/1697, 0.18%), of which one was PIVC-related (1/1697, 0.06%), and 2% (34/1697) of participants had adverse skin reactions. Total costs were not significantly different between groups. Overall, 66% (1130/1709) PIVCs required dressing reinforcement.
INTERPRETATION: Current dressing and securement methods are commonly associated with PIVC failure, adverse events, and poor durability, with simultaneous use of multiple products commonly required. Innovation is urgently needed.