Povidine-Iodine Effect on Nasal Mucosa Cilia in Rhinoplasty Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Preoperative nasal mucosa cilia (NMC) function
研究概览
简要总结
The goal of the proposed study is to identify PVP-I at 1.25% as an appropriate intranasal topical preparation for patients undergoing rhinoplasty with no effect on the nasal mucosa cilia (NMC) or olfaction using the saccharin transit time (STT) test as a method for evaluating NMC function. PVP-I has been shown to be viricidal in the upper aerodigestive tract. This study is highly-relevant, as protection for individuals with a high risk of exposure to respiratory pathogens has become increasingly important in the setting of recent viral epidemics such as SARS-CoV-2. Septorhinoplasty is commonly performed throughout the world and there is a paucity of standardized testing in surgical facilities. Much of our understanding of the current COVID-19 pandemic is extrapolated from MERS and SARS data. It is our hope that this study's relevance for the current pandemic remains so in the unfortunate event of another pandemic in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients at Boston Medical Center undergoing septorhinoplasty, without inferior turbinate reduction
- •Normal range baseline saccharin transit time (STT)
- •SARS-CoV-2 Testing Negative at the time of the procedure o Per institution guidelines, patients scheduled for surgery undergo a preoperative nasopharyngeal test within 24 hours of their procedure - per institution protocols.
排除标准
- •Known history of:
- •thyroid dysfunction
- •renal disease
- •autoimmune disease affecting the upper airway
- •immunocompromised
- •pregnant, breastfeeding
- •Patients determined to have dysfunctional nasal mucosa cilia (NMC) function based on a STT time of ≥30 minutes
- •Patients with a contraindication to Povidone-iodine (PVP-I) including history of allergy/anaphylaxis to PVP-I, labile thyroid disease, history of contact dermatitis, active radioiodine therapy, pregnancy/nursing
研究组 & 干预措施
group 1
All participants will have PVP-I at 1.25% administered as an intranasal topical preparation prior undergoing rhinoplasty
干预措施: Povidone-Iodine (PVP-I) (Drug)
结局指标
主要结局
Preoperative nasal mucosa cilia (NMC) function
时间窗: baseline
NMC will be assessed with the saccharin transit time (STT) test. This test is done by the examiner inserting sodium saccharin particle on the upper surface of the inferior nasal turbinate.The patient is instructed to swallow once every minute and notify the examiner when they notice a sweet taste. The distance from the start of the mucociliary membrane to far wall of pharynx is measured with a probe. From this measurement, the mean velocity is calculated compared to the total time from the start of the test. Dysfunction is defined as a STT \>30.
Postoperative nasal mucosa cilia (NMC) function
时间窗: 5 weeks
NMC will be assessed with the saccharin transit time (STT) test. This test is done by the examiner inserting sodium saccharin particle on the upper surface of the inferior nasal turbinate.The patient is instructed to swallow once every minute and notify the examiner when they notice a sweet taste. The distance from the start of the mucociliary membrane to far wall of pharynx is measured with a probe. From this measurement, the mean velocity is calculated compared to the total time from the start of the test. Dysfunction is defined as a STT \>30.
次要结局
- Change in self reported symptoms of nasal blockage or obstruction(baseline, 5 weeks)
- Change in olfactory function(baseline, 5 weeks)
- Change in quality of life based on sino-nasal symptoms(baseline, 5 weeks)
- Preoperative clinical examination of nasal mucosa(baseline)
- Post operative clinical examination of nasal mucosa(5 weeks)