NCT02116608

Treatment of Tracheostomy Granulomas

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 31 Days – 17 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Granuloma
• Tracheostomy

Interventions

Type	Name	Description
DRUG	Betadine	Apply locally as needed.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-09-05
• Completion: 2019-09-05
• First posted: 2014-04-17
• Last updated: 2021-09-13
• Results posted: 2021-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study