Treatment of Tracheostomy Granulomas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Success and Failure Rates for Each Treatment Method
研究概览
简要总结
This study plans to learn more about the different ways used to treat tracheostomy granulomas. Investigators want to see which standard of care method (steroid application, silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.
详细描述
Upon joining the study patients will be assigned to one of the three treatment groups (steroid application, silver nitrate, and betadine). These three treatments are standard of care and patients would have been treated with one of them anyway. Patients will be followed for an observation period of six weeks with follow-up appointments, per standard of care, every two weeks (+/- 3 days) in order for a physician to evaluate if the treatment method is working. If during a follow-up visit, the physician determines the treatment method is not working, the follow-up period will end and participation in the study will be complete. In addition, if a patient is given a different form of treatment during the observation period, such as in the emergency department or through their primary care physician, the follow-up period will end and participation in the study will be complete.
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
- 31 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children's Hospital Colorado inpatient or outpatient
- •31 days to 17 years (inclusive)
- •Needs treatment for a tracheostomy granuloma
排除标准
- •Tracheostomy granuloma has been treated in the last two weeks
研究组 & 干预措施
Group 1: Betadine
Apply locally as needed.
干预措施: Betadine (Drug)
Group 2: Silver Nitrate
Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated.
干预措施: Silver Nitrate (Drug)
Group 3: Hydrocortisone Butyrate Cream, 1.0%
Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.
干预措施: Hydrocortisone Butyrate Cream, 1.0% (Drug)
结局指标
主要结局
Success and Failure Rates for Each Treatment Method
时间窗: Over 6 weeks
Definition of success: The investigators are defining successful treatment of tracheostomy granulomas as a decrease in the frequency of granulomas over a six week observation period using the assigned treatment or partial or complete resolution of the granuloma. Partial resolution is defined as 25-75% resolution and complete resolution is defined as greater than 75% resolution. Definition of failure: The investigators are defining a treatment as a failure if during the six week observation period of using the assigned treatment, there is either no improvement in the resolution or there has been an increase in size or frequency of tracheostomy granulomas.
Categorical Improvement (Degree of Improvement)
时间窗: Over 6 Weeks
Categorical success/failure data. the size of the granuloma will be measured and recorded. The percent circumference will also be measured. The approximate percent decrease in the granuloma size will be determined to determine the category subject's change in granuloma: i. Complete resolution: \>90% improvement (Score = 4) ii. Improvement: 50 - 90% improvement (Score = 3) iii. Minimal improvement: \< 50% improvement (Score = 2) iv. No improvement (Score = 1) v. Worsening (Score = 0)
次要结局
- Length of Time Between Administration of the Treatment and the Determination of Treatment Failure, if Applicable(Over 6 weeks)