Study of the Concordance of the Measurements Between the Evaluation of the Area of a Wound by the Technique of Transparent (Gold Standard) Compared to the Evaluation of the Area by the Algorithm of a Decision Support System (Wound-size)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 主要终点
- WoundCare (AKA WoundTrack) the principal investigator
研究概览
简要总结
The goal of this clinical trial is to compare the evaluation of a wound area and wound tissue content made by different methods on patient population with need for directed wound healing.
The main question test of the concordance of the measurements between the evaluation of the area of a wound by the technique of transparent (Gold standard) compared to the evaluation of the area by the algorithm of a decision support system (WoundSize)
Patient wounds will be examined:
- by eye by the principal investigator
- using a ruler by the principal investigator
- by WoundCare algorithms (AKA WoundTrack) using smartphone photography by the principal investigator
- tracing the outline of the wound using a transparent sheet by the principal investigator
- by eye by a second investigator
- using a ruler by a second investigator
- by WoundCare (AKA WoundTrack) algorithms using smartphone photography by a second investigator.
- tracing the outline of the wound using a transparent sheet by the second investigator
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Patient suffering from a wound requiring controlled healing ranging from 4 to 150 cm²
- •Age greater than or equal to 18 years old
- •Person affiliated to a social security scheme or beneficiary of such a scheme
- •Person having received complete information on the organization of the research and having signed informed consent.
- •Wound that can be taken in one photo in its entirety.
排除标准
- •Person with a medical condition which, in the judgment of the investigator, is not compatible with participation in the study
- •Wound on a part of the body that would make the person participating in the photos of the wound identifiable (tattoo, piercing, birthmark, etc.).
- •Several wounds are in the photo.
- •Pregnant, parturient or breastfeeding women
- •Person deprived of liberty by a judicial or administrative decision
- •Adult subject to a measure of legal protection (guardianship, curatorship, safeguard of justice) or unable to express their consent, persons subject to psychiatric care.
结局指标
主要结局
WoundCare (AKA WoundTrack) the principal investigator
时间窗: During the study inclusion visit
Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the principal investigator
Transparent sheet by principal investigator
时间窗: During the study inclusion visit
Surface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the principal investigator
次要结局
- Eye by the principal investigator(During the study inclusion visit)
- Ruler by the second investigator(During the study inclusion visit)
- WoundCare (AKA WoundTrack) the second investigator(During the study inclusion visit)
- Ruler by the principal investigator(During the study inclusion visit)
- Eye by the second investigator(During the study inclusion visit)
- Transparent sheet by second investigator(During the study inclusion visit)
研究者
MAXANT Guillaume
Principal investigator
Central Hospital, Nancy, France