Treatment of Tracheostomy Granulomas

NCT02116608 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 13-2819
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Granuloma; Tracheostomy

Outcome Measures

Primary Outcomes (2)

• Success and Failure Rates for Each Treatment Method

  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.

  Over 6 weeks

• Categorical Improvement (Degree of Improvement)

  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)

  Over 6 Weeks

Secondary Outcomes (1)

• Length of Time Between Administration of the Treatment and the Determination of Treatment Failure, if Applicable

  Over 6 weeks

Study Arms (3)

Group 1: Betadine

ACTIVE COMPARATOR

Apply locally as needed.

Drug: Betadine

Group 2: Silver Nitrate

ACTIVE COMPARATOR

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

Group 3: Hydrocortisone Butyrate Cream, 1.0%

ACTIVE COMPARATOR

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%

Interventions

Betadine DRUG

Apply locally as needed.

Group 1: Betadine

Silver Nitrate DRUG

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.

Group 2: Silver Nitrate

Hydrocortisone Butyrate Cream, 1.0% DRUG

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.

Group 3: Hydrocortisone Butyrate Cream, 1.0%

Eligibility Criteria

• Age: 31 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children's Hospital Colorado inpatient or outpatient
• days to 17 years (inclusive)
• Needs treatment for a tracheostomy granuloma

You may not qualify if:

• Tracheostomy granuloma has been treated in the last two weeks

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

• 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.

  PMID: 12514373 BACKGROUND

• 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.

  PMID: 21996151 BACKGROUND

• 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.

  PMID: 20425857 BACKGROUND

• 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.

  PMID: 22612258 BACKGROUND

MeSH Terms

Conditions

Granuloma

Interventions

Povidone-Iodine; Silver Nitrate

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Nitrates; Nitric Acid; Nitrogen Compounds; Silver Compounds

Results Point of Contact

• Title: Jeremy Prager, MD
• Organization: University of Colorado Denver

clinicalresearchsupportcenter@ucdenver.edu

3037241111

Study Officials

• Jeremy Prager, MD

  1. University of Colorado School of Medicine, Department of Otolaryngology 2. Children's Hospital Colorado, Department of Pediatric Otolaryngology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: September 1, 2014
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: September 13, 2021
• Results First Posted: September 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)