TY - JOUR
T1 - Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE)
T2 - a pragmatic, randomised controlled, superiority trial
AU - Rickard, Claire M.
AU - Marsh, Nicole
AU - Webster, Joan
AU - Runnegar, Naomi
AU - Larsen, Emily
AU - McGrail, Matthew R.
AU - Fullerton, Fiona
AU - Bettington, Emilie
AU - Whitty, Jennifer A.
AU - Choudhury, Md Abu
AU - Tuffaha, Haitham
AU - Corley, Amanda
AU - McMillan, David J.
AU - Fraser, John F.
AU - Marshall, Andrea P.
AU - Playford, E. Geoffrey
N1 - Funding Information:
CMR, NM, JW, and JFF conceptualised the study. CMR, NM, JW, MRM, JAW, HT, DJM, and EGP designed the protocol. CMR, NM, JW, MRM, JAW, DJM, JFF, APM, and EGP applied for funding. JAW, EB, and HT did the health economic analysis. MAC and DJM did microbiological analysis. NR and EGP adjudicated infections. NM and EL were responsible for project management. NM, JW, FF, EL, and EGP recruited patients, collected data, and supervised research nurses. CMR, NM, EL, and MRM were responsible for data management. MRM did the statistical analysis. CMR did the first draft of the manuscript, and all authors reviewed the manuscript before publication.
Funding Information:
CMR's employer has received on her behalf, investigator initiated research grants and unrestricted educational grants from 3M, Adhezion, Bard, Baxter, B Braun, BD Medical, Centurion Medical Products, Entrotech, and Medtronic, and consultancy fees from 3M, Bard, BBraun, BD Medical, and ResQDevices. EL's employer has received on her behalf, consultancy fees from 3M. NM's employer has received on her behalf, investigator initiated research grants and unrestricted educational grants from 3M, BD Medical, Centurion Medical Products, and Entrotech. All other authors declare no competing interests.
Publisher Copyright:
© 2018 Elsevier Ltd
PY - 2018/8/4
Y1 - 2018/8/4
N2 - Background: Two billion peripheral intravenous catheters (PIVCs) are used globally each year, but optimal dressing and securement methods are not well established. We aimed to compare the efficacy and costs of three alternative approaches to standard non-bordered polyurethane dressings. Methods: We did a pragmatic, randomised controlled, parallel-group superiority trial at two hospitals in Queensland, Australia. Eligible patients were aged 18 years or older and required PIVC insertion for clinical treatment, which was expected to be required for longer than 24 h. Patients were randomly assigned (1:1:1:1) via a centralised web-based randomisation service using random block sizes, stratified by hospital, to receive tissue adhesive with polyurethane dressing, bordered polyurethane dressing, a securement device with polyurethane dressing, or polyurethane dressing (control). Randomisation was concealed before allocation. 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. The primary outcome was all-cause PIVC failure (as a composite of complete dislodgement, occlusion, phlebitis, and infection [primary bloodstream infection or local infection]). Analysis was by modified intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000769987. Findings: Between March 18, 2013, and Sept 9, 2014, we randomly assigned 1807 patients to receive tissue adhesive with polyurethane (n=446), bordered polyurethane (n=454), securement device with polyurethane (n=453), or polyurethane (n=454); 1697 patients comprised the modified intention-to-treat population. 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 poplyurethane group (–1·2% [–7·9% to 5·4%], p=0·73), and 180 (43%) of 422 patients in the polyurethane group had PIVC failure. 17 patients in the tissue adhesive with polyurethane group, two patients in the bordered polyurethane group, eight patients in the securement device with polyurethane group, and seven patients in the polyurethane group had skin adverse events. Total costs of the trial interventions did not differ significantly between groups. Interpretation: Current dressing and securement methods are commonly associated with PIVC failure and poor durability, with simultaneous use of multiple products commonly required. Cost is currently the main factor that determines product choice. Innovations to achieve effective, durable dressings and securements, and randomised controlled trials assessing their effectiveness are urgently needed. Funding: Australian National Health and Medical Research Council.
AB - Background: Two billion peripheral intravenous catheters (PIVCs) are used globally each year, but optimal dressing and securement methods are not well established. We aimed to compare the efficacy and costs of three alternative approaches to standard non-bordered polyurethane dressings. Methods: We did a pragmatic, randomised controlled, parallel-group superiority trial at two hospitals in Queensland, Australia. Eligible patients were aged 18 years or older and required PIVC insertion for clinical treatment, which was expected to be required for longer than 24 h. Patients were randomly assigned (1:1:1:1) via a centralised web-based randomisation service using random block sizes, stratified by hospital, to receive tissue adhesive with polyurethane dressing, bordered polyurethane dressing, a securement device with polyurethane dressing, or polyurethane dressing (control). Randomisation was concealed before allocation. 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. The primary outcome was all-cause PIVC failure (as a composite of complete dislodgement, occlusion, phlebitis, and infection [primary bloodstream infection or local infection]). Analysis was by modified intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000769987. Findings: Between March 18, 2013, and Sept 9, 2014, we randomly assigned 1807 patients to receive tissue adhesive with polyurethane (n=446), bordered polyurethane (n=454), securement device with polyurethane (n=453), or polyurethane (n=454); 1697 patients comprised the modified intention-to-treat population. 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 poplyurethane group (–1·2% [–7·9% to 5·4%], p=0·73), and 180 (43%) of 422 patients in the polyurethane group had PIVC failure. 17 patients in the tissue adhesive with polyurethane group, two patients in the bordered polyurethane group, eight patients in the securement device with polyurethane group, and seven patients in the polyurethane group had skin adverse events. Total costs of the trial interventions did not differ significantly between groups. Interpretation: Current dressing and securement methods are commonly associated with PIVC failure and poor durability, with simultaneous use of multiple products commonly required. Cost is currently the main factor that determines product choice. Innovations to achieve effective, durable dressings and securements, and randomised controlled trials assessing their effectiveness are urgently needed. Funding: Australian National Health and Medical Research Council.
UR - http://www.scopus.com/inward/record.url?scp=85053734165&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(18)31380-1
DO - 10.1016/S0140-6736(18)31380-1
M3 - Article
C2 - 30057103
AN - SCOPUS:85053734165
SN - 0140-6736
VL - 392
SP - 419
EP - 430
JO - The Lancet
JF - The Lancet
IS - 10145
ER -