Treatment of Tracheostomy Granulomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Tracheostomy Granulomas

Conditions
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Granuloma, Tracheostomy

Intervention / Treatment
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* Drug: Betadine
* Drug: Silver Nitrate
* Drug: Hydrocortisone Butyrate Cream, 1.0%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children's Hospital Colorado inpatient or outpatient 31 days to 17 years (inclusive) Needs treatment for a tracheostomy granuloma Exclusion Criteria: Tracheostomy granuloma has been treated in the last two weeks

Ages Eligible for Study
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Minimum Age: 31 Days
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Betadine<br>Apply locally as needed. | Drug: Betadine<br>* Apply locally as needed.<br>|
| Active Comparator: Group 2: Silver Nitrate<br>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. | Drug: Silver Nitrate<br>* 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.<br>|
| Active Comparator: Group 3: Hydrocortisone Butyrate Cream, 1.0%<br>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. | Drug: Hydrocortisone Butyrate Cream, 1.0%<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success and Failure Rates for Each Treatment Method | 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. | Over 6 weeks | 
| Categorical Improvement (Degree of Improvement) | 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) | Over 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Time Between Administration of the Treatment and the Determination of Treatment Failure, if Applicable | Over the 6 week treatment period, the time from administration of the treatment to the time of treatment failure, if it occurs, will be evaluated and documented. | Over 6 weeks |