Protect peripheral intravenous catheters: a study protocol for a randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial)

Abstract

Introduction: Peripheral intravenous catheters (PIVCs) are the most commonly used vascular access device in hospitalised patients. Yet PIVCs may be complicated by local or systemic infections leading to increased healthcare costs. Chlorhexidine gluconate (CHG)-impregnated dressings may help reduce PIVC-related infectious complications but have not yet been evaluated. 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 multicentre, superiority, randomised clinical and cost-effectiveness trial with internal pilot, conducted across three centres in Australia and France. Patients (adults and children aged ≥6 years) requiring one PIVC for ≥48 hours are eligible. We will exclude patients with emergent PIVCs, known CHG allergy, skin injury at site of insertion or previous trial enrolment. Patients will be randomised to 3M Tegaderm Antimicrobial IV Advanced Securement dressing or standard care group. For the internal pilot, 300 patients will be enrolled to test protocol feasibility (eligibility, recruitment, retention, protocol fidelity, missing data and satisfaction of participants and staff), primary endpoint for internal pilot, assessed by independent data safety monitoring committee. Clinical outcomes will not be reviewed. Following feasibility assessment, the remaining 2624 (1312 per trial arm) patients will be enrolled following the same methods. The primary endpoint is a composite of catheter-related infectious complications and phlebitis. Recruitment began on 3 May 2023.; Ethics and Dissemination: The protocol was approved by Ouest I ethic committee in France and by The Queensland Children's Hospital Human Research Ethics Committee in Australia. The findings will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.; Trial Registration Number: NCT05741866.; Competing Interests: Competing interests: CMR’s employer (The University of Queensland or Griffith University) has received unrestricted research grants on her behalf from BD, Cardinal Health, Eloquest and consultancy payments from 3M, BD, BBraun, and ITL Biomedical. AU’s employer (The University of Queensland or Griffith University) has received unrestricted research grants or consultancies on her behalf from BD, 3M, Sterile Care and Medline. NMM— Griffith University and The University of Queensland have received on her behalf investigator-initiated research grants or consultancies from Cardinal Health, 3M, Eloquest, Medline and Becton Dickinson. AC has received unrestricted investigator-initiated research grants, paid to her employer (Griffith University), from Cardinal Health, 3 M and Eloquest. TMK’s employer (The University of Queensland or Griffith University) has received unrestricted research grants on her behalf from BD, and consultancy payments from 3M, BD, BBraun, Medical Specialties Australia, and Smiths Medical. OM, BD and JG received funding for congress attendance, and research funding from Becton Dickinson and 3M. JB’s employer (Griffith University) has received unrestricted research grants on his behalf from BD and Navi Technologies, and consultancy payments from 3M, and BD. COB has no conflicts of interest. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)