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