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临床试验/NCT06192095
NCT06192095已完成不适用

Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Change of dressing method

研究概览

简要总结

Long-term indwelling vascular catheters including central venous catheters, peripherally inserted central venous catheters, arterial catheters are often essential for medical care. During the routine care, some patients may experience skin damage around the catheter insertion site due to allergic reactions to the catheter dressing material, physical damage during dressing changes, leading to infection, prolonged hospitalization, and unexpected medical costs. If the condition is mild, it may increase the number of dressing changes. In severe cases, it may require changing to a different dressing method, using medication, or even removing the indwelling catheter. This study investigates the efficacy of liquid skin barrier film in preventing skin damage around long-term indwelling vascular catheters. In this randomized controlled trial, the participants aged 0 to less than 18 years who has long-term indwelling vascular catheters inserted at National Taiwan University Hospital Yunlin Branch will be recruited. At the time of indwelling vascular catheter insertion, the subjects are randomly assigned to the control group or the experimental group. The control group received standard care according to the hospital's guidelines, using a sterile transparent dressing or gauze to cover the catheter insertion site. The experimental group first applied liquid skin barrier film to the skin, then applied a sterile transparent dressing or gauze to cover the catheter insertion site. The patients are followed for two weeks. The primary endpoint is the need for change of dressing, use of medication, or removal of the catheter due to skin damage around the catheter insertion site. The secondary endpoints are skin breakdown, number of dressing changes, and incidence of bloodstream infection. It is expected that the research results may change the standard clinical management of long-term indwelling vascular catheters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 0-17 years (less than 18 years old)
  • Receiving a central venous catheter, peripherally inserted central catheter, or arterial line insertion

排除标准

  • The skin around the catheter insertion site is not inact
  • Known allergic to liquid skin barrier film

结局指标

主要结局

Change of dressing method

时间窗: 0-14 days

Change of dressing method due to injury/allergy of skin around the vascular indwelling catheters

Vascular indwelling catheter removal

时间窗: 0-14 days

Need of catheter removal due to injury/allergy of skin around

Medical treatment for the skin

时间窗: 0-14 days

Need of medical treatment (topical, oral, intravenous) due to injury/allergy of skin around the vascular indwelling catheters

次要结局

  • Catheter-related bloodstream infection(0-14 days)
  • Pain degree/severity of the skin(0-14 days)
  • Occurrence of skin injury/allergy(0-14 days)
  • Number of dressing changes(0-14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

National Taiwan University Clinical Trial Center

National Taiwan University Hospital Yunlin Branch

National Taiwan University Hospital

研究点 (2)

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