Treatment of Tracheostomy Granulomas

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Granuloma; Tracheostomy

Treatments: Drug: Betadine; Drug: Silver Nitrate; Drug: Hydrocortisone Butyrate Cream, 1.0%

Study type: Interventional

Funder types: Other

Identifiers

NCT02116608

13-2819

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 31 days to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Group 1: Betadine

Active Comparator group

Description:

Apply locally as needed.

Treatment:

Drug: Betadine

Group 2: Silver Nitrate

Active Comparator group

Description:

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.

Treatment:

Drug: Silver Nitrate

Group 3: Hydrocortisone Butyrate Cream, 1.0%

Active Comparator group

Description:

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.

Treatment:

Drug: Hydrocortisone Butyrate Cream, 1.0%