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- Title
SECURE-ment bundles to prevent peripheral vascular access device failure -- the SECURE-PVAD trial: study protocol for a pilot randomized control trial.
- Authors
CORLEY, AMANDA; ULLMAN, AMANDA J.; MARSH, NICOLE; LARSEN, EMILY N.; MIHALA, GABOR; HARRIS, PATRICK N. A.; RICKARD, CLAIRE M.
- Abstract
Introduction: Peripheral vascular access devices (PVADs) are widely used, but failure is unacceptably common with up to 69% failing before treatment is complete. PVAD securement reduces failure, but the optimal way to achieve this is unclear. Tapes and supplementary securement product use is common, however, rigorous testing of these to reduce PVAD failure remains unexplored. Methods and analysis: In adult medical-surgical wards at a tertiary hospital, this pilot randomized controlled trial tests standard care (bordered polyurethane dressing plus nonsterile tape over the extension tubing) against two securement interventions (intervention one: standard care plus two sterile tape strips over the PVAD hub; intervention two: intervention one plus a tubular bandage). Patients >18 years of age requiring a PVAD for >24 hours are eligible. Patients with laboratory-confirmed positive blood cultures within 24 hours of screening, known allergy to study products, current or high-risk of skin tear, or non-English speaking without interpreter are excluded. Sample size is 35 per trial arm, and central randomization is computer-generated with allocation concealed until entry. Patients and clinical staff cannot be blinded to treatment allocation. However, infection outcomes are assessed by a blinded investigator. Primary outcome is study feasibility. Secondary outcomes (PVAD failure, dwell time, skin adverse events, PVAD colonization, and cost) are compared between groups. Feasibility outcomes are reported descriptively.
- Subjects
BLOOD; BLOOD vessels; CATHETERIZATION complications; CELL culture; CONFIDENCE intervals; EVALUATION of medical care; MEDICAL equipment; HEALTH outcome assessment; PILOT projects; RANDOMIZED controlled trials; TREATMENT effectiveness; MEDICAL equipment reliability; TREATMENT duration; PERIPHERALLY inserted central catheters; KAPLAN-Meier estimator; TAPING &; strapping; TERTIARY care
- Publication
Vascular Access, 2019, Vol 13, Issue 3, p8
- ISSN
1913-6692
- Publication type
Article