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临床试验/NCT04890678
NCT04890678已完成不适用

The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment: a Clinical Test in 10 Belgian Nursing Homes

University Ghent2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月20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
40
试验地点
2
主要终点
Pressure ulcer incidence

研究概览

简要总结

Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.

It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • At risk of pressure ulcer development based on a Braden score ≤ 17 or pressure ulcer category III or IV
  • Bedbound or chair bound
  • Aged ≥ 65

排除标准

  • Short-stay residents (expected length of stay ≤14 days)
  • End of life care
  • Medical contraindication for patient repositioning/turning

结局指标

主要结局

Pressure ulcer incidence

时间窗: 30 days

Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system

Pressure ulcer healing

时间窗: 30 days

Healing of pressure ulcers category III and IV during the 30-day study period - using the Pressure Ulcer Scale for Healing Tool (PUSH)

次要结局

  • Comfort(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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