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临床试验/NCT02311127
NCT02311127已完成不适用

Comparing SecurAcath Versus StatLock to Secure Peripherally Inserted Central Catheters: a Randomised, Open Trial

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
Time needed for dressing change

研究概览

简要总结

Peripherally inserted central catheters (PICCs ) are used for the administration of intravenous fluids and for blood sampling. PICCs may remain in place for weeks to months and are safeguarded from migration or accidental dislodgement by securement devices. Different types of these devices are available. StatLock® (C.R. Bard) is a stabilization device with an adhesive anchor pad. The catheter wings of the PICC must be placed over the posts then the system is closed with "gull-wings" . StatLock® has to be changed weekly. Healthcare providers have to pay attention to prevent accidental catheter dislodgement during the renewal procedure. SecurAcath® (Interrad Medical) is a new securement device to the European market. The device uses a small subcutaneous anchor to secure the PICC. One of the advantages compared to adhesive stabilization devices, is a reduction in maintenance time by simplifying dressing changes and subsequently staff time. It is described that nurses report that care is left undone due to low staffing levels. Therefore, investigation of nursing time savings with the support of technology is imperative. SecurAcath® remains in place for life of the PICC and therefore has the potential to reduce the time for dressing change as there is no need for weekly device change. The objective of this study is to measure nursing time for dressing change and explore inserting and removal issues and patient experiences.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • •Polyurethane PICC insertion
  • •Dutch speaking patient, able to give informed consent
  • •Intravenous treatment is administered in the University Hospitals Leuven

排除标准

  • •patients with known allergy to nickel or ethylene oxide

研究组 & 干预措施

SecurAcath

Experimental

Subcutaneous securement

干预措施: SecurAcath (Device)

StatLock

Active Comparator

Adhesive securement

干预措施: StatLock (Device)

结局指标

主要结局

Time needed for dressing change

时间窗: weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks

次要结局

  • Number of accidental removals(at catheter removal which is expected on an average after 2 weeks or up to 26 weeks)
  • Number of catheters that migrated(weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks)
  • Catheter-related infection(at catheter removal which is expected on an average after 2 weeks or up to 26 weeks)
  • Pain at catheter entry site related to device(every week with the catheter dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks)
  • Ease of use of the device(at placement (day 1) and at catheter removal which is expected on an average after 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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