• J Tissue Viability · May 2020

    Randomized Controlled Trial

    Smile - Secure my intravenous line effectively: A pilot randomised controlled trial of peripheral intravenous catheter securement in paediatrics.

    • Tricia M Kleidon, Claire M Rickard, Victoria Gibson, Gabor Mihala, Jessica A Schults, Hui Grace Xu, Michelle J Bauer, Nicole Marsh, Emily N Larsen, Paula Cattanach, and Amanda J Ullman.
    • Queensland Children's Hospital, Queensland, Australia; Alliance for Vascular Access Teaching and Research Group, Menzies Health Institute Queensland, Australia; Nursing & Midwifery Research Centre, Royal Brisbane and Women's Hospital, Queensland, Australia. Electronic address: tricia.kleidon@health.qld.gov.au.
    • J Tissue Viability. 2020 May 1; 29 (2): 82-90.

    AimEvaluate the feasibility of an efficacy randomised control trial (RCT) of paediatric peripheral intravenous catheter (PIVC) securement to prevent failure without resultant skin damage.MethodsA 3-arm, pilot RCT in an Australian paediatric hospital. Random assignment of 330 children to receive (i) bordered polyurethane dressing (BPU) + non-sterile foam (NSF), (ii) integrated securement dressing (ISD) + sterile foam (SF), or (iii) tissue adhesive (TA)+ NSF. Primary outcomes were feasibility and PIVC failure. Secondary outcomes included: skin/bloodstream infection; occlusion; infiltration; dislodgement; phlebitis; dwell; serious adverse events; acceptability and microbial colonisation of catheter tips, wound site, and foam.ResultsMost feasibility outcomes were confirmed; 98% of eligible patients consented, 96% received their allocated dressing and no patients were lost to follow up. Eligilbility feasibility (58%) was not met. 11 randomised patients did not require a PIVC. Of 319 patients receiving a PIVC (20,716 PIVC-hours), a significant reduction in PIVC failure was demonstrated with ISD, 31/107 (29%, p = 0.017) compared to BPU, 47/105 (45%). Although not statistically significant, compared to BPU, TA 34/107 (32%, p = 0.052) was associated with less PIVC failure. On Cox regression, no securement intervention significantly reduced PIVC failure. Older age (HR 0.92; 95% confidence interval [CI] 0.88-0.96; p = <0.01), no infection at baseline (HR 0.51; 95% CI 0.34-0.78) and insertion by vascular access specialist (HR 0.40; 95% CI 0.26-0.64) were significantly associated with reduced failure (p < 0.05).ConclusionISD and TA had reduced PIVC failure compared to BPU. A large efficacy trial to test statistical differences is feasible and needed.Copyright © 2020 Tissue Viability Society. All rights reserved.

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