GranulomaPhase 4NCT02116608
Treatment of Tracheostomy Granulomas
A Phase 4 study testing Betadine, Silver Nitrate and Hydrocortisone Butyrate Cream, 1.0% in people with Granuloma and Tracheostomy, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 31 days to 17 years
- Conditions the study is for
- Granuloma, Tracheostomy
- What is being tested?
- Betadine, Silver Nitrate and Hydrocortisone Butyrate Cream, 1.0%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 5 Sep 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children's Hospital Colorado inpatient or outpatient
- 31 days to 17 years (inclusive)
- Needs treatment for a tracheostomy granuloma
Who cannot join
- Tracheostomy granuloma has been treated in the last two weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Granuloma, Tracheostomy
- Being tested
- Betadine, Silver Nitrate, Hydrocortisone Butyrate Cream, 1.0%
- Medical subject headings
- Granuloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetadineDrug
Apply locally as needed.
Silver NitrateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Betadine | Active comparator | Apply locally as needed. Receives: 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. Receives: 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. Receives: Drug: Hydrocortisone Butyrate Cream, 1.0% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- 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)
Measured: Over 6 Weeks
Secondary outcomes (1)
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.
Measured: Over 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startSep 2014
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GranulomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Prager, MD, Principal investigator, 1. University of Colorado School of Medicine, Department of Otolaryngology 2. Children's Hospital Colorado, Department of Pediatric Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116608
- Sponsor's protocol ID
- 13-2819
- Status last verified
- Aug 2021
- First submitted
- 15 Apr 2014
- Last updated
- 13 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12514373Chen 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.
PubMed 21996151Al-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.
PubMed 20425857McShane 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.
PubMed 22612258
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Tracheostomy Granulomas
- ClinicalTrials.gov ID
- NCT02116608
- Acronym / sponsor ID
- 13-2819
- Conditions
- Granuloma, Tracheostomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Betadine | Active comparator | Drug: BetadineApply locally as needed. |
| Group 2: Silver Nitrate | Active comparator | Drug: Silver NitrateArzol 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 3: Hydrocortisone Butyrate Cream, 1.0% | Active comparator | 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. |
Who may qualify
- Ages
- 31 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children's Hospital Colorado inpatient or outpatient
- 31 days to 17 years (inclusive)
- Needs treatment for a tracheostomy granuloma
Key exclusion criteria (1 listed)
- Tracheostomy granuloma has been treated in the last two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetadineApply locally as needed. | Drug | Group 1: Betadine |
| Silver NitrateArzol 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 | Group 2: Silver Nitrate |
| 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 | Group 3: Hydrocortisone Butyrate Cream, 1.0% |
Primary outcome
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.
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)
1 secondary outcome
Length of Time Between Administration of the Treatment and the Determination of Treatment Failure, if Applicable
Time frame: Over 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12514373Yaremchuk K. Regular tracheostomy tube changes to prevent formation of granulation tissue. Laryngoscope. 2003 Jan;113(1):1-10. doi: 10.1097/00005537-200301000-00001.
- Background: PubMed 21996151Chen 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.
- Background: PubMed 20425857Al-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.
- Background: PubMed 22612258McShane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Prager, MD principal investigator
1. University of Colorado School of Medicine, Department of Otolaryngology 2. Children's Hospital Colorado, Department of Pediatric Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betadine, Silver Nitrate and Hydrocortisone Butyrate Cream, 1.0% in people with Granuloma and Tracheostomy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success and Failure Rates for Each Treatment Method (time frame: Over 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02116608, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.