Comparison of Showerpatch Versus Other Measures to Protect Intravenous Catheter Entry Site During Bathing Activities
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Self-reported autonomy score regarding bathing activities
研究概览
简要总结
Venous catheters are necessary for the treatment of many patients. Showering with a venous catheter is often prohibited due to the infection risk when the insertion site becomes wet. Therefore these patients are challenged to keep the catheter insertion site dry and always covered with a dressing. Washing themselves is often impossible without assistance of a nurse or significant other. For patients with a catheter connected to an infusion line, it is even more difficult. Showerpatch is a newly developed dressing that safeguards the insertion site of an IV catheter from water during bathing activities. The purpose of this trial is to evaluate the impact of the availability of Showerpatch by comparing the outcomes in patients regarding the patient's autonomy in bathing activities, the material use and the time needed from caregivers in home care. Additionally qualitative data on patient's bathing activities and the use of Showerpatch will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able to read and speak Dutch and to fill out a web-based questionnaire
- •patients with an IV catheter (peripheral catheter, midline, peripherally inserted central catheter (PICC), Central Venous catheter (CVC), tunnelled catheter or implantable port) with an expected dwell time IV therapy of at least 14 days and with or without a prospect of discharge to the home setting with the IV catheter in situ in the foreseen study period
- •physically able to wash themselves
- •with access to the internet
排除标准
- •Bedridden patients
- •Patients who have already participated in an earlier stage of the ISIC study
- •Patients with more than one lumen of the catheter continuously connected to an infusion line
结局指标
主要结局
Self-reported autonomy score regarding bathing activities
时间窗: Weekly until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
autonomy regarding bathing activities will be scored on a newly developed autonomy scale on a weekly basis
次要结局
- Time needed from a caregiver(Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks)
- Laboratory-Confirmed Bloodstream Infection(Until catheter removal which is expected on an average after 2 weeks or up to 8 weeks)
- Catheter dressing status: wet(Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks)
- Catheter dressing status: loose(Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks)
- Number and type of bathing activities(Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks)
- Material consumption regarding IV entry site care for bathing activities(Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks)
- Clinical signs of local infection(Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks)