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Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): A pragmatic, randomised controlled, superiority trial

The Lancet Aug 02, 2018

Rickard CM, et al. - A pragmatic, randomized controlled, parallel-group superiority trial at two hospitals in Queensland, Australia was conducted to compare the effectiveness and costs of three alternative approaches to standard non-bordered polyurethane dressings. Researchers reported that existing dressing and securement approaches were frequently correlated with peripheral intravenous catheter (PIVC) failure and poor durability, and use of multiple products simultaneously was common. The main factor that currently determines product choice is cost.

Methods

  • Included patients were aged 18 years or older and required PIVC insertion for clinical treatment, which was expected to be required for longer than 24 hours.
  • Via a centralized web-based randomization service using random block sizes stratified by hospital, subjects were randomly assigned (1:1:1:1) to receive tissue adhesive with polyurethane dressing, bordered polyurethane dressing, a securement device with polyurethane dressing, or polyurethane dressing (control).
  • Before allocation, randomization was concealed.
  • Patients, clinicians, and research staff were not masked because of the nature of the intervention, but infections were adjudicated by a physician who was masked to treatment allocation.
  • All-cause PIVC failure (as a composite of complete dislodgement, occlusion, phlebitis, and infection [primary bloodstream infection or local infection]) was the primary outcome and analysis was by modified intention to treat.

Results

  • Researchers randomly assigned 1,807 subjects to receive tissue adhesive with polyurethane (n=446), bordered polyurethane (n=454), securement device with polyurethane (n=453), or polyurethane (n=454); 1,697 patients comprised the modified intention-to-treat population between March 18, 2013, and Sept 9, 2014.
  • It was observed that 163 (38%) of 427 patients in the tissue adhesive with polyurethane group (absolute risk difference -4·5% [95% CI -11·1 to 2·1%], p=0·19), 169 (40%) of 423 of patients in the bordered polyurethane group (–2·7% [–9·3 to 3·9%] p=0·44), 176 (41%) of 425 patients in the securement device with polyurethane group (–1·2% [–7·9% to 5·4%], p=0·73), and 180 (43%) of 422 patients in the polyurethane group had PIVC failure.
  • It was noted that 17 patients in the tissue adhesive with polyurethane group, 2 patients in the bordered polyurethane group, 8 patients in the securement device with polyurethane group, and 7 patients in the polyurethane group had skin adverse events.
  • According to the findings, total costs of the trial interventions did not vary significantly between groups.
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