Trial reportAntimicrobial resistance and infection control2026
An international randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial).
Trial report in Antimicrobial resistance and infection control, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05741866 (Protect PIVCs), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Protect PIVCs: An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs).
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPeripheral 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.
methodsThe 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.
resultsBetween 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.
conclusionThis 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 registrationClinicalTrials.gov NCT05741866.
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