A Prospective, Single-blind, Multi-center Clinical Study Evaluating the Use of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds.
试验速览
- 阶段
- 不适用
- 入组人数
- 367
- 试验地点
- 14
- 主要终点
- Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity.
研究概览
简要总结
This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).
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
- •Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
- •18 years or older
排除标准
- •Treatment with an investigational drug within 1 month before study enrolment
- •Subjects with recent (<30 days) biopsy of target wound
- •Subjects with wounds that cannot be completely imaged by study device due to anatomic location
- •Inability to consent
- •Any contra-indication to routine wound care and/or monitoring
结局指标
主要结局
Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity.
时间窗: 1 year
Superiority in sensitivity of clinical signs and symptoms (CSS) and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone to identify wounds with moderate/heavy bacterial load Non-Inferiority of specificity of CSS and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone with region of indifference of 10% to identify wounds with moderate/heavy bacterial load
次要结局
- Estimation of sensitivity and specificity of MolecuLight i:X alone(1.5 years)