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Completed

NCT Number: NCT02116608

Treatment of Tracheostomy Granulomas

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.

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Key information

Conditions

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

Age range

31 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betadine

Drug

Apply locally as needed.

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.

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.

Primary outcomes

  1. Success and Failure Rates for Each Treatment Method

    Time frame: 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)

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2014
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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