Clinical trial NCT02116608: Treatment of Tracheostomy Granulomas
Official title: Treatment of Tracheostomy Granulomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Granuloma
Tracheostomy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 26
Sex: ALL
Minimum age (years): 31
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Success and Failure Rates for Each Treatment Method
timeFrame: Over 6 weeks
measure: Categorical Improvement (Degree of Improvement)
timeFrame: Over 6 Weeks
Secondary outcomes:
measure: Length of Time Between Administration of the Treatment and the Determination of Treatment Failure, if Applicable
timeFrame: Over 6 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: 1. University of Colorado School of Medicine, Department of Otolaryngology 2. Children's Hospital Colorado, Department of Pediatric Otolaryngology
name: Jeremy Prager, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yaremchuk K. Regular tracheostomy tube changes to prevent formation of granulation tissue. Laryngoscope. 2003 Jan;113(1):1-10. doi: 10.1097/00005537-200301000-00001.
citation: Chen C, Bent JP, Parikh SR. Powered debridement of suprastomal granulation tissue to facilitate pediatric tracheotomy decannulation. Int J Pediatr Otorhinolaryngol. 2011 Dec;75(12):1558-61. doi: 10.1016/j.ijporl.2011.09.007. Epub 2011 Oct 11.
citation: Al-Samri M, Mitchell I, Drummond DS, Bjornson C. Tracheostomy in children: a population-based experience over 17 years. Pediatr Pulmonol. 2010 May;45(5):487-93. doi: 10.1002/ppul.21206.
citation: McShane DB, Bellet JS. Treatment of hypergranulation tissue with high potency topical corticosteroids in children. Pediatr Dermatol. 2012 Sep-Oct;29(5):675-8. doi: 10.1111/j.1525-1470.2012.01724.x. Epub 2012 May 21.