Phase 4 N=26 Randomized Treatment

Treatment of Tracheostomy Granulomas

Granuloma · Tracheostomy

Bottom Line

View on ClinicalTrials.gov: NCT02116608 ↗

Enrolled (actual)

Serious AEs

11.5%

Results posted

Sep 2021

Primary outcome: Primary: Success and Failure Rates for Each Treatment Method — 6; 3; 5; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Betadine (Drug); Silver Nitrate (Drug); Hydrocortisone Butyrate Cream, 1.0% (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Success and Failure Rates for Each Treatment Method	6; 3; 5; 3; 4; 2	—
PRIMARY Categorical Improvement (Degree of Improvement)	0; 2; 2; 1; 1; 0	—
SECONDARY Length of Time Between Administration of the Treatment and the Determination of Treatment Failure, if Applicable	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02116608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.