NCT05196880已完成不适用
A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load
研究概览
简要总结
This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm. The primary objective is to evaluate the diagnostic accuracy of MolecuLight fluorescence in identifying biofilm as validated by gold standard SEM imaging.
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
- 否
入选标准
- •Patients presenting with acute or chronic wounds
- •18 years or older
- •Willing to consent
排除标准
- •Treatment with an investigational drug within 1 month of enrolment
- •Any contra-indication to regular wound care
- •Inability or unwillingness to consent
研究组 & 干预措施
ARM 1
Patients with negative clinical suspicion of Biofilm containing wounds(CSB-).
干预措施: MolecuLight DX Imaging Device (Device)
ARM 2
Patients with positive clinical suspicion of Biofilm containing wounds(CSB+)
干预措施: MolecuLight DX Imaging Device (Device)
结局指标
主要结局
Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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