A Double-blind, Intervention, Post-marketing Investigation to Identify Subjects Who Are Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers, Using PU Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 433
- 试验地点
- 6
- 主要终点
- Number of pressure ulcers developed between visit 1 and 2
研究概览
简要总结
A double blind, non randomized, multicenter investigation
详细描述
The study consists of 2 evaluations/visits.
Evaluation/visit 1: Takes place in connection with admission to the hospital. Informed consent, inclusion and exclusion criteria are assessed as well as assessment of skin type and inspection of the entire body skin. Pregnancy test on women of childbearing potential, height, weight, blood pressure and body temperature are measured. Questions about demography, health conditions, previous illnesses, nicotine habits. Risk assessment for pressure ulcers (Modified Norton or RAPS-scale) is carried out according to the hospital usual routine. Examination with PU sensor will be performed.
Evaluation/visit 2: Takes place in connection with the discharge from the hospital or 4 weeks after visit 1 if the research subject is still hospitalized. Full body skin inspection to see possible onset of pressure ulcers. Review of the research subject's medical records as well as review of nursing notes from the hospital where the research subject has been discharged from, to find any notes about pressure ulcers. The study participation is then terminated for the research subject.
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
盲法说明
The medical device will give an ID number but the results from the measurement will be masked until data base is locked (DBL). The data from the measurement will be available after DBL
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
- •Given their written consent to participate in the study
- •Male or female between ≥18 years and ≤ 64 years with a reduced mobility, where the hospitalization may involve a risk that the person may become less active or Male or female ≥65 years
排除标准
- •Existing pressure ulcer or damage to the skin around the sacrum where the PU sensor plate and pillow are to be placed
- •Fever ≥38 ºC, within 30 minutes before the examination with PU sensor
- •Difficulty lying still in supine position during the examination with PU sensor, which takes 5 to 10 minutes
- •Known allergy or sensitivity to any of the materials in PU sensor that gets in contact with the skin on the sacrum
- •Body weight ≥200 kg
- •Previous participation in the study
- •Mental inability, or language difficulties that results in difficulty to understand the meaning of participation in the study and / or signing the study consent,
结局指标
主要结局
Number of pressure ulcers developed between visit 1 and 2
时间窗: Up to 4 weeks
This outcome is to evaluate if the subjects that have been assessed as at risk of developing pressure ulcers (using PU sensor) have actually developed pressure ulcers with a greater probability than those assessed as not at risk
次要结局
- Incidence of adverse events (AEs) and adverse device effects (ADEs)(Up to 2 days)