School of Nursing Midwifery and Social Work, UQ Centre for Clinical Research, The University of Queensland, Herston, Queensland, Australia
Alliance for Vascular Access Teaching and Research, School of Nursing and Midwifery, Griffith University, Nathan, Queensland, Australia.
BMJ Open. 2024 Jul 16;14(7):e084313. doi: 10.1136/bmjopen-2024-084313.
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.
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.
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.
NCT05741866.
外周静脉导管（PIVC）是住院患者中最常用的血管通路装置。然而，PIVC 可能会引起局部或全身感染，导致医疗保健成本增加。氯己定葡萄糖酸盐（CHG）浸渍敷料可能有助于减少 PIVC 相关感染并发症，但尚未进行评估。我们假设与标准聚氨酯敷料相比，浸渍 CHG 的透明敷料在预防 PIVC 相关感染并发症和静脉炎方面是安全、有效且具有成本效益的。
ProP 试验是一项多中心、优势、随机临床试验和成本效益试验，具有内部试点，在澳大利亚和法国的三个中心进行。需要至少使用 PIVC 48 小时的成年和儿童（≥6 岁）患者符合条件。我们将排除紧急 PIVC、已知对 CHG 过敏、插入部位皮肤损伤或之前参加试验的患者。患者将被随机分配到 3M Tegaderm 抗菌 IV 高级固定敷料或标准护理组。对于内部试点，将招募 300 名患者以测试方案的可行性（合格性、招募、保留率、方案保真度、缺失数据以及参与者和工作人员的满意度），由独立的数据安全监测委员会评估内部试点的主要终点。不会对临床结果进行评估。在可行性评估后，将按照相同的方法招募其余 2624 名（每个试验组 1312 名）患者。主要终点是导管相关感染并发症和静脉炎的综合指标。招募于 2023 年 5 月 3 日开始。
该方案已获得法国 Ouest I 伦理委员会和澳大利亚昆士兰儿童医院人类研究伦理委员会的批准。研究结果将通过在科学会议上的报告和在同行评议期刊上的发表来传播。
NCT05741866。
