跳至主要内容
临床试验/NCT02705443
NCT02705443Unknown不适用

Early Identification of Suspected Deep Tissue Injury (sDTI) Utilizing Long-Wave Thermographic Imaging (LWIT)

Wound Vision1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer

研究概览

简要总结

The purpose of this study is to further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or lack thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures (temperature). These signatures will be measured and quantitatively recorded using long-wave infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their pathophysiological evolution. Additionally, the LWIT physiological data will be cross-compared to the gold standard of visual assessment and other current standards of wound evaluation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 18 years of age or older
  • Can tolerate position changes ≥ 10 minutes
  • Non-pregnant

排除标准

  • Therapies/treatments cannot be safely suspended to for an imaging session
  • Non-English speaking

结局指标

主要结局

Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer

时间窗: Up to 25 days

Sensitivity and specificity of a thermographic anomaly that progresses to a stageable pressure ulcer

Number of anatomical areas with intact skin and a thermographic anomaly that do not progress to a stageable pressure ulcer

时间窗: Up to 25 days

Sensitivity and specificity of a thermographic anomaly that does not progress to a stageable pressure ulcer

次要结局

  • Temperature change associated with anatomical areas after a stageable pressure ulcer occurs(Up to 25 days)

研究者

发起方
Wound Vision
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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