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

• DOI: 10.2196/preprints.52313
• Publication Date: 2023-08-31T05:35:20Z
• Authors: Claire M Rickard; Bertrand Drugeon; Amanda Ullman; Nicole Marsh; Amanda Corley; Daner Ball; Catherine O'Brien; Tricia M Kleidon; Jérémy Guenezan; Raphael Couvreur; Kate McCarthy; Sabrina Seguin; Guillaume Batiot; Josh Byrnes; Jessica Schults; Syeda Farah Zahir; Olivier Mimoz
• Keywords: Central venous catheter

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