An international randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial)

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BACKGROUND: Peripheral intravenous catheters (PIVCs) are extensively used in hospitals worldwide and frequently associated with complications. Phlebitis is a common complication and may indicate infection, while infectious events, although uncommon, contribute to antimicrobial use and healthcare-associated infection. Chlorhexidine gluconate (CHG) impregnated dressings effectively prevent infections in central venous catheters but evidence for PIVC use is lacking. We assessed the feasibility and preliminary clinical outcomes of CHG-impregnated dressings for PIVCs. METHODS: The ProP trial was a multi-centre, open-label, two-arm, parallel adaptive randomised controlled trial (RCT) in Australia and France. Adult and paediatric patients in emergency and acute settings who were expected to require a PIVC for ≥48 hours were eligible. Randomisation was centralised (1:1 ratio; allocation concealed; stratified by site) to either a CHG-impregnated dressing or a standard polyurethane dressing. In Phase I, feasibility outcomes included eligibility, recruitment, retention, protocol fidelity, missing data and satisfaction, with exploratory analysis of clinical outcomes. Phase II was planned to definitively compare clinical outcomes (composite infectious complications of local infection, catheter tip colonisation, PIVC-related bloodstream infection (BSI), and/or phlebitis), however progression to Phase II depended on pre-defined Phase I feasibility criteria. RESULTS: Between May 2023 and March 2024, 300 patients were enrolled at three hospitals. Most feasibility criteria achieved pre-specified targets including 92% recruitment, 99% retention, 99% protocol fidelity, 0% missing data, and >98% satisfaction for both participant and staff. However, eligibility was 76%, (<80% feasibility threshold), triggering trial cessation. Composite infectious complications and/or phlebitis occurred in 19% of control participants and 20% of the intervention participants. This included local infection (1% control; 0% intervention), PIVC-tip colonisation (3% control; 1% intervention), phlebitis (14% control; 18% intervention), and PIVC-BSI (none in either group). All adverse events were minor, and none required dressing removal. CONCLUSION: This study can inform the design of a definitive trial to assess the clinical and economic effectiveness of CHG-impregnated dressings for PIVCs, including refinement of the eligibility criteria and primary outcome. TRIAL REGISTRATION: ClinicalTrials.gov NCT05741866.

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