Photodisinfection for the Treatment of Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- SNOT-22
研究概览
简要总结
The purpose of this study is to determine whether the use of light and a topically applied photosensitizer can relieve symptoms and clinically improve patients with chronic rhinosinusitis.
详细描述
This clinical trial will be a prospective, randomized, single-center study utilizing two treatment assignments and a control group. The study is expected to enroll a total of 48 subjects. The intent of the study is to evaluate a single versus double treatment of photodisinfection in men and women suffering from chronic persistent rhinosinusitis with and without nasal polyposis. Each photodisinfection treatment group will be compared to a control group receiving saline irrigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •history of chronic rhinosinusitis with and without nasal polyposis
- •no antibiotics within 4 weeks
- •no oral steroid use within 4 weeks
- •no topical steroid use within 2 weeks
- •endoscopic sinus surgery greater than 6 months previously
排除标准
- •acute respiratory infection within last 2 weeks
- •septal deviation restricting sinus access
- •known allergy to methylene blue
- •pregnant or breast feeding
结局指标
主要结局
SNOT-22
时间窗: 6 months
The Sino-Nasal Outcome Test (SNOT-22) has been widely adopted in clinical practice and has been proved to be the most suitable and validated sinonasal outcome scoring system. The SNOT-22 is a disease-specific, quality-of-life-related measure of sinonasal function. Low score indicates good outcome.
次要结局
- Microbiome evaluation(6 months)