Treatment of Tracheostomy Granulomas

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT02116608
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 3
• Actual Duration (Months): 60.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Granuloma; Tracheostomy	Drug: Betadine; Drug: Silver Nitrate; Drug: Hydrocortisone Butyrate Cream, 1.0%	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Tracheostomy Granulomas
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Sep 5, 2019
• Actual Study Completion Date: Sep 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1: Betadine Apply locally as needed.	Drug: Betadine; Apply locally as needed.
Active Comparator: Group 2: 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: 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.
Active Comparator: Group 3: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Success and Failure Rates for Each Treatment Method [Over 6 weeks]

   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.

2. Categorical Improvement (Degree of Improvement) [Over 6 Weeks]

   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)

Secondary Outcome Measures

1. Length of Time Between Administration of the Treatment and the Determination of Treatment Failure, if Applicable [Over 6 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 31 Days to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Jeremy Prager, MD, 1. University of Colorado School of Medicine, Department of Otolaryngology 2. Children's Hospital Colorado, Department of Pediatric Otolaryngology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 7, 2016

More Information

Publications

• 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.
• 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.
• 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.
• Yaremchuk K. Regular tracheostomy tube changes to prevent formation of granulation tissue. Laryngoscope. 2003 Jan;113(1):1-10.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02116608
• Other Study ID Numbers: 13-2819
• First Posted: Apr 17, 2014
• Last Update Posted: Sep 13, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Granuloma; Povidone-Iodine; Silver Nitrate; Hydrocortisone; Hydrocortisone-17-butyrate

Study Results

Participant Flow

Arm/Group Title	Group 1: Betadine	Group 2: Hydrocortisone Butyrate Cream, 1.0%	Group 3: Silver Nitrate
Arm/Group Description	Apply locally as needed. Betadine: Apply locally as needed.	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. 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.	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. 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.
Period Title: Overall Study
STARTED	9	9	8
COMPLETED	9	7	7
NOT COMPLETED	0	2	1

Baseline Characteristics

Arm/Group Title	Group 1: Betadine	Group 2: Hydrocortisone Butyrate Cream, 1.0%	Group 3: Silver Nitrate	Total
Arm/Group Description	Apply locally as needed. Betadine: Apply locally as needed.	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. 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.	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. 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.	Total of all reporting groups
Overall Participants	9	9	8	26
Age (Count of Participants)
<=18 years	9 100%	9 100%	8 100%	26 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (days) [Mean (Full Range) ]
Mean (Full Range) [days]	1190.778	256.333	897.625	777.115
Sex: Female, Male (Count of Participants)
Female	5 55.6%	5 55.6%	3 37.5%	13 50%
Male	4 44.4%	4 44.4%	5 62.5%	13 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 33.3%	1 11.1%	1 12.5%	5 19.2%
Not Hispanic or Latino	6 66.7%	6 66.7%	6 75%	18 69.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 11.1%	1 11.1%	2 25%	4 15.4%
White	8 88.9%	6 66.7%	3 37.5%	17 65.4%
More than one race	0 0%	0 0%	2 25%	2 7.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%	9 100%	8 100%	26 100%

Outcome Measures

1. Primary Outcome

Title	Success and Failure Rates for Each Treatment Method
Description	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.
Time Frame	Over 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Betadine	Group 2: Hydrocortisone Butyrate Cream, 1.0%	Group 3: Silver Nitrate
Arm/Group Description	Apply locally as needed. Betadine: Apply locally as needed.	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. 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.	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. 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.
Measure Participants	9	7	7
Success	6 66.7%	3 33.3%	5 62.5%
Failure	3 33.3%	4 44.4%	2 25%

2. Primary Outcome

Title	Categorical Improvement (Degree of Improvement)
Description	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)
Time Frame	Over 6 Weeks

Outcome Measure Data

Analysis Population Description

This outcome measure was initially grouped in error under another outcome measure at registration.

Arm/Group Title	Group 1: Betadine	Group 2: Hydrocortisone Butyrate Cream, 1.0%	Group 3: Silver Nitrate
Arm/Group Description	Apply locally as needed. Betadine: Apply locally as needed.	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. 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.	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. 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.
Measure Participants	9	7	7
Worsening	0 0%	2 22.2%	2 25%
No improvement	1 11.1%	1 11.1%	0 0%
Minimal improvement: < 50% improvement	2 22.2%	1 11.1%	0 0%
Improvement: 50-90% improvement	2 22.2%	0 0%	0 0%
Complete resolution: >90% improvement	4 44.4%	3 33.3%	5 62.5%

3. Secondary Outcome

Title	Length of Time Between Administration of the Treatment and the Determination of Treatment Failure, if Applicable
Description	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.
Time Frame	Over 6 weeks

Outcome Measure Data

Analysis Population Description

No data was collected for this outcome measure.

Arm/Group Title	Group 1: Betadine	Group 2: Hydrocortisone Butyrate Cream, 1.0%	Group 3: Silver Nitrate
Arm/Group Description	Apply locally as needed. Betadine: Apply locally as needed.	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. 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.	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. 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.
Measure Participants	0	0	0

Adverse Events

Time Frame	6 Weeks
Arm/Group Title	Group 1: Betadine		Group 2: Hydrocortisone Butyrate Cream, 1.0%		Group 3: Silver Nitrate
Arm/Group Description	Apply locally as needed. Betadine: Apply locally as needed.		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. 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.		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. 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.
All Cause Mortality
	Group 1: Betadine		Group 2: Hydrocortisone Butyrate Cream, 1.0%		Group 3: Silver Nitrate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Serious Adverse Events
	Group 1: Betadine		Group 2: Hydrocortisone Butyrate Cream, 1.0%		Group 3: Silver Nitrate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		2/9 (22.2%)		1/8 (12.5%)
Infections and infestations
Central line infection	0/9 (0%)	0	0/9 (0%)	0	1/8 (12.5%)	1
Injury, poisoning and procedural complications
Death	0/9 (0%)	0	1/9 (11.1%)	1	0/8 (0%)	0
Respiratory, thoracic and mediastinal disorders
Viral Respiratory Infection	0/9 (0%)	0	1/9 (11.1%)	1	0/8 (0%)	0
Pneumonia	0/9 (0%)	0	1/9 (11.1%)	1	0/8 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1: Betadine		Group 2: Hydrocortisone Butyrate Cream, 1.0%		Group 3: Silver Nitrate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/9 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.