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临床试验/NCT04625348
NCT04625348已完成不适用

A Multicentre Clinical Test of the Ultracore Repose® Mattress (Frontier Therapeutics Ltd) to Prevent Pressure Ulcers Cat. II-IV in Belgian Nursing Homes

University Ghent7 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年2月15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
7
主要终点
Incidence rate of pressure ulcers Cat. II-IV

研究概览

简要总结

A mixed method desgin study will be conducted to study pressure ulcer incidence Cat. II-IV (including deep- tissue injury,unstageable), not associated with the use of medical devices, on the Ultracore Repose® mattress (Frontier therapeutics Ltd) and to study differences in caretakers' experiences and perceptions when using the Ultracore Repose® mattress versus the Repose overlay mattress®

详细描述

Quantitative part:

Before the start of the study, nurses on the participating wards will be educated by the researcher about skin observation, pressure ulcer classification, risk assessment, risk assessment, and use of the Ultracore Repose® mattress (Frontier therapeutics Ltd).

Skin assessment and risk assessment are performed on a daily basis by the staff nurses. Reliability testing will be done by the researcher on a weekly basis and without pre-announcement. Reliability checks and compliance with the protocol will be completed by the researcher as well as the collection of additional data.

Qualitative part

Three focus groups will be set- up at the end of the study to provide insights into how caregivers think about the product and to provide a deeper understanding of the difference between the use of the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress).The researcher will encourage group interactions to capture the data and to provide a more comprehensive understanding of experiences and perceptions of using the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress). Non-verbal communication will also be captured in each focus group.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • High risk of pressure ulcers (Braden score < 12) and/or pressure ulcer category 1
  • Bedbound (> 8 hours in bed) or chair bound (> 8 hours in chair)
  • Aged > 65 years

排除标准

  • Pressure ulcer Category II-IV, deep tissue injury (DTI) or unstageable pressure ulcer
  • Expected length of stay < 2 weeks
  • End of life care
  • Medical contraindication for use of static air support devices

结局指标

主要结局

Incidence rate of pressure ulcers Cat. II-IV

时间窗: 14 days

Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices

次要结局

  • caretakers' experiences and perceptions(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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