Trial Outcomes & Findings for Treatment of Tracheostomy Granulomas (NCT NCT02116608)
NCT ID: NCT02116608
Last Updated: 2021-09-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Over 6 weeks
Results posted on
2021-09-13
Participant Flow
Participant milestones
| Measure |
Group 1: Betadine
Apply locally as needed.
Betadine: Apply locally as needed.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Betadine
Apply locally as needed.
Betadine: Apply locally as needed.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Ethnicity data was not collected for the 3 participants who did not complete the study.
Baseline characteristics by cohort
| Measure |
Group 1: Betadine
n=9 Participants
Apply locally as needed.
Betadine: Apply locally as needed.
|
Group 2: Hydrocortisone Butyrate Cream, 1.0%
n=9 Participants
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.
|
Group 3: Silver Nitrate
n=8 Participants
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
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
8 Participants
n=8 Participants
|
26 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=26 Participants
|
|
Age, Continuous
|
1190.778 days
n=9 Participants
|
256.333 days
n=9 Participants
|
897.625 days
n=8 Participants
|
777.115 days
n=26 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=8 Participants
|
13 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=9 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
1 Participants
n=7 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
1 Participants
n=7 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
5 Participants
n=23 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
6 Participants
n=7 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
6 Participants
n=7 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
18 Participants
n=23 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=23 Participants • Ethnicity data was not collected for the 3 participants who did not complete the study.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=23 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=23 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=23 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
1 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
2 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
4 Participants
n=23 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
6 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
3 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
17 Participants
n=23 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
2 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
2 Participants
n=23 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=7 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
0 Participants
n=23 Participants • Race data was not collected for the 3 participants who did not complete the study.
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
8 participants
n=8 Participants
|
26 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Over 6 weeksDefinition 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.
Outcome measures
| Measure |
Group 1: Betadine
n=9 Participants
Apply locally as needed.
Betadine: Apply locally as needed.
|
Group 2: Hydrocortisone Butyrate Cream, 1.0%
n=7 Participants
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.
|
Group 3: Silver Nitrate
n=7 Participants
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.
|
|---|---|---|---|
|
Success and Failure Rates for Each Treatment Method
Success
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Success and Failure Rates for Each Treatment Method
Failure
|
3 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Over 6 WeeksPopulation: This outcome measure was initially grouped in error under another outcome measure at registration.
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)
Outcome measures
| Measure |
Group 1: Betadine
n=9 Participants
Apply locally as needed.
Betadine: Apply locally as needed.
|
Group 2: Hydrocortisone Butyrate Cream, 1.0%
n=7 Participants
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.
|
Group 3: Silver Nitrate
n=7 Participants
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.
|
|---|---|---|---|
|
Categorical Improvement (Degree of Improvement)
Worsening
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Categorical Improvement (Degree of Improvement)
No improvement
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Categorical Improvement (Degree of Improvement)
Minimal improvement: < 50% improvement
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Categorical Improvement (Degree of Improvement)
Improvement: 50-90% improvement
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Categorical Improvement (Degree of Improvement)
Complete resolution: >90% improvement
|
4 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Over 6 weeksPopulation: No data was collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
Adverse Events
Group 1: Betadine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Hydrocortisone Butyrate Cream, 1.0%
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Group 3: Silver Nitrate
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Betadine
n=9 participants at risk
Apply locally as needed.
Betadine: Apply locally as needed.
|
Group 2: Hydrocortisone Butyrate Cream, 1.0%
n=9 participants at risk
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.
|
Group 3: Silver Nitrate
n=8 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Death
|
0.00%
0/9 • 6 Weeks
|
11.1%
1/9 • Number of events 1 • 6 Weeks
|
0.00%
0/8 • 6 Weeks
|
|
Infections and infestations
Central line infection
|
0.00%
0/9 • 6 Weeks
|
0.00%
0/9 • 6 Weeks
|
12.5%
1/8 • Number of events 1 • 6 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Viral Respiratory Infection
|
0.00%
0/9 • 6 Weeks
|
11.1%
1/9 • Number of events 1 • 6 Weeks
|
0.00%
0/8 • 6 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/9 • 6 Weeks
|
11.1%
1/9 • Number of events 1 • 6 Weeks
|
0.00%
0/8 • 6 Weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place