Protect PIVC s: Study protocol for a randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP Trial). (Preprint)

Abstract

Introduction: Peripheral intravenous catheters (PIVCs) are the most common vascular access device with most hospitalised patients receiving at least one during hospital admission. Traditionally, a transparent dressing alone is considered adequate to safely secure a PIVC, regardless of the potential risk of local and systemic infections. Although PIVCs have the lowest incidence of proven infection of all vascular access devices (0.1%, 0.5 per 1000 catheter-days), with nearly 2 billion purchased worldwide each year, the absolute risk of infectious complications and related costs are similar to or even greater than those for other vascular access devices. Chlorhexidine gluconate (CHG)-impregnated dressings are widely used to reduce the infectious risk of central venous and arterial catheters but their value in preventing PIVC-related infectious complications has not yet been evaluated in patients. We hypothesise an impregnated CHG transparent dressing, in comparison to standard polyurethane dressing, will be safe, effective, and cost-effective in protecting against PIVC-related infectious complications and phlebitis. Methods and analysis: The ProP Trial is a two-arm, superiority, randomised-controlled trial conducted in two centres in Australia and one centre in France. Patients (adults and children aged ≥6 years) requiring one PIVC for ≥48 hours will be eligible. Exclusion criteria include catheter placement under emergency conditions, burned, non-intact or diseased skin at catheter insertion site, known allergy to CHG or transparent dressing adhesives, and previous participation in the trial. The trial will be conducted in two phases. First, 300 participants will be enrolled as an internal pilot to test protocol feasibility without review of clinical outcomes. An independent data safety monitoring committee will assess the feasibility of pursuing the full trial, of 2624 (1312 in each study group) patients. Patients will be randomised 1:1 to 3M™ Tegaderm™ Antimicrobial IV Advanced Securement dressing or standard care group using a central, web-based randomisation service, with varied block sizes of 4 and 6 and stratification by hospital. Recruitment began on 3rd May, 2023. Other than the type of randomised dressing used to secure the PIVCs, the insertion, maintenance and removal of PIVCs will follow standard practices at the participating sites. The primary endpoint is a composite of catheter-related infectious complications (local and bloodstream infections) and phlebitis. Ethics and dissemination: Human Research Ethics Committee will be gained at participating sites. Eligible patients will receive oral and written information and will be enrolled after giving written consent. For children, parental or legal guardian consent will be required for inclusion in the study. The findings will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. Trial registration: NCT05741866