NCT07646938已完成不适用
A Prospective, Clinical Evaluation of the MolecuLightDX+ With OxySight Module to Observe the Clinical Utility of Tissue Oxygenation, Bacterial Fluorescence and Thermal Signatures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Tissue oxygenation informing fluorescence-guided debridement
研究概览
简要总结
This is a prospective, clinical evaluation of the MolecuLightDX+ with OxySight Module in wound care.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Male or female patients presenting with a wound
- •A wound is > 1 cm2 in area
- •18+ years old
- •Willing to consent
排除标准
- •Contraindication to debridement
- •Undergoing radio- or chemotherapy
- •Wound located in a difficult to image location
- •Any condition deemed by the investigator to interfere with safety or data validity
- •Inability or unwillingness to consent
结局指标
主要结局
Tissue oxygenation informing fluorescence-guided debridement
时间窗: up to 1 month
Evaluate the feasibility of using tissue oxygenation (StO2) to further inform fluorescence-guided debridement.
Tissue oxygenation changes before and after debridement
时间窗: up to 1 month
Observe and quantify changes in tissue oxygenation (StO2) from before to immediately after fluorescence-guided debridement.
次要结局
未报告次要终点
研究者
研究点 (1)
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