Hypergranulation Tissue; Gastrostomy Tube SitePhase 4NCT02398539
Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue
A Phase 4 study testing Silver Nitrate and Triamcinolone in people with Hypergranulation Tissue; Gastrostomy Tube Site, run by Akron Children's Hospital at 1 site in United States.
Trial summary
This protocol describes a randomized, two arm clinical trial comparing two topical treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are randomized to either group 1or group 2 treatments: Maximum duration of therapy is 4 weeks. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hypergranulation Tissue; Gastrostomy Tube Site
- What is being tested?
- Silver Nitrate and Triamcinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients <18
- Evaluated for hypergranulation at the G-tube site
- Inpatient and out-patient
Who cannot join
- Children not meeting the above criteia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Eloise Lemon, 330-543-3193, elemon@chmca.org
Ana Frabotta, PNP
About this study
Official title: Randomized Clinical Trial Comparing Silver Nitrate Application With Topical Corticosteroids for Hypergranulation Tissue at Gastrostomy Sites
This protocol describes a randomized, two arm clinical trial comparing two topical treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are randomized to either group 1or group 2 treatments:
Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at the discretion of the investigator or if there is resolution of the of the hypergranulation tissue.
- Being tested
- Silver Nitrate, Triamcinolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver NitrateDrug
Silver Nitrate Sticks
TriamcinoloneDrug
0.5% cream
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician. Receives: Drug: Silver Nitrate |
| Group 2 | Active comparator | Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver. Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal reduction in granulation tissue
Measured: During maximum of 4 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypergranulation Tissue; Gastrostomy Tube SiteStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eloise Lemon, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398539
- Sponsor's protocol ID
- 150110
- Status last verified
- May 2015
- First submitted
- 20 Mar 2015
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Silver Nitrate Application With Topical Corticosteroids for Hypergranulation Tissue at Gastrostomy Sites
- ClinicalTrials.gov ID
- NCT02398539
- Acronym / sponsor ID
- 150110
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol describes a randomized, two arm clinical trial comparing two topical treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are randomized to either group 1or group 2 treatments:
Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at the discretion of the investigator or if there is resolution of the of the hypergranulation tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Silver NitrateSilver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician. |
| Group 2 | Active comparator | Drug: TriamcinoloneTriamcinolone cream, 0.5% applied three times per day by the patient's caregiver. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric patients <18
- Evaluated for hypergranulation at the G-tube site
- Inpatient and out-patient
Key exclusion criteria (1 listed)
- Children not meeting the above criteia
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 |
|---|---|---|
| Silver NitrateSilver Nitrate Sticks | Drug | Group 1 |
| Triamcinolone0.5% cream | Drug | Group 2 |
Primary outcome
Maximal reduction in granulation tissue
Time frame: During maximum of 4 weeks of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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.
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 Silver Nitrate and Triamcinolone in people with Hypergranulation Tissue; Gastrostomy Tube Site, run by Akron Children's Hospital 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: status not confirmed, as of the sponsor's last update on 29 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eloise Lemon, MSN, MHA, RN ((330) 543-3193, ELEMON@CHMCA.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal reduction in granulation tissue (time frame: During maximum of 4 weeks of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2015; AzTrials last refreshed its copy on 28 Oct 2026.