Granuloma, Tracheostomy
Conditions
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.
Interventions
DRUGBetadine
Apply locally as needed.
DRUGSilver 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.
DRUGHydrocortisone 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
31 Days to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Betadine Apply locally as needed.
Betadine: Apply locally as needed. | 9 |
| Group 2: 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.
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. | 9 |
| Group 3: 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.
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. | 8 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1: Betadine | Group 2: Hydrocortisone Butyrate Cream, 1.0% | Group 3: Silver Nitrate | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 9 Participants | 8 Participants | 26 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1190.778 days | 256.333 days | 897.625 days | 777.115 days |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 3 Participants | 17 Participants |
| Region of Enrollment United States | 9 participants | 9 participants | 8 participants | 26 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 1 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 9 | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 2 / 9 | 1 / 8 |
Outcome results
Primary
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)
Time frame: Over 6 Weeks
Population: This outcome measure was initially grouped in error under another outcome measure at registration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Betadine | Categorical Improvement (Degree of Improvement) | Minimal improvement: < 50% improvement | 2 Participants |
| Group 1: Betadine | Categorical Improvement (Degree of Improvement) | No improvement | 1 Participants |
| Group 1: Betadine | Categorical Improvement (Degree of Improvement) | Worsening | 0 Participants |
| Group 1: Betadine | Categorical Improvement (Degree of Improvement) | Complete resolution: >90% improvement | 4 Participants |
| Group 1: Betadine | Categorical Improvement (Degree of Improvement) | Improvement: 50-90% improvement | 2 Participants |
| Group 2: Hydrocortisone Butyrate Cream, 1.0% | Categorical Improvement (Degree of Improvement) | Complete resolution: >90% improvement | 3 Participants |
| Group 2: Hydrocortisone Butyrate Cream, 1.0% | Categorical Improvement (Degree of Improvement) | Minimal improvement: < 50% improvement | 1 Participants |
| Group 2: Hydrocortisone Butyrate Cream, 1.0% | Categorical Improvement (Degree of Improvement) | Improvement: 50-90% improvement | 0 Participants |
| Group 2: Hydrocortisone Butyrate Cream, 1.0% | Categorical Improvement (Degree of Improvement) | Worsening | 2 Participants |
| Group 2: Hydrocortisone Butyrate Cream, 1.0% | Categorical Improvement (Degree of Improvement) | No improvement | 1 Participants |
| Group 3: Silver Nitrate | Categorical Improvement (Degree of Improvement) | Minimal improvement: < 50% improvement | 0 Participants |
| Group 3: Silver Nitrate | Categorical Improvement (Degree of Improvement) | Worsening | 2 Participants |
| Group 3: Silver Nitrate | Categorical Improvement (Degree of Improvement) | Improvement: 50-90% improvement | 0 Participants |
| Group 3: Silver Nitrate | Categorical Improvement (Degree of Improvement) | Complete resolution: >90% improvement | 5 Participants |
| Group 3: Silver Nitrate | Categorical Improvement (Degree of Improvement) | No improvement | 0 Participants |
Primary
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.
Time frame: Over 6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Betadine | Success and Failure Rates for Each Treatment Method | Success | 6 Participants |
| Group 1: Betadine | Success and Failure Rates for Each Treatment Method | Failure | 3 Participants |
| Group 2: Hydrocortisone Butyrate Cream, 1.0% | Success and Failure Rates for Each Treatment Method | Success | 3 Participants |
| Group 2: Hydrocortisone Butyrate Cream, 1.0% | Success and Failure Rates for Each Treatment Method | Failure | 4 Participants |
| Group 3: Silver Nitrate | Success and Failure Rates for Each Treatment Method | Success | 5 Participants |
| Group 3: Silver Nitrate | Success and Failure Rates for Each Treatment Method | Failure | 2 Participants |
Secondary
Length of Time Between Administration of the Treatment and the Determination of Treatment Failure, if Applicable
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
Population: No data was collected for this outcome measure.