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临床试验/NCT03518190
NCT03518190已完成不适用

Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年7月30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
31
试验地点
1
主要终点
Early detection of pressure induced tissue damage

研究概览

简要总结

The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage

详细描述

During pressure injuries formation early sub dermal bio signal appear. By applying infrared spectroscopy at a suspicions injury site on the human body and obtaining a reflected infrared light infrared allows to determine early formation of a pressure injury/

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with stage 1 pressure injury
  • Patients with high risk of developing pressure injury

排除标准

  • Patients with stage 2 pressure injury or higher

结局指标

主要结局

Early detection of pressure induced tissue damage

时间窗: Ten minutes

Infrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury

Pressure injury probability

时间窗: Ten minutes

Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yehuda Ullmann MD

Head of Plastic Surgery Department

Rambam Health Care Campus

研究点 (1)

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