- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02398539
Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Eloise Lemon, MSN, MHA, RN
- Phone Number: (330) 543-3193
- Email: ELEMON@CHMCA.ORG
Study Locations
-
-
Ohio
-
Akron, Ohio, United States, 44308
- Recruiting
- Akron Children's Hospital
-
Contact:
- Eloise Lemon
- Phone Number: 330-543-3193
- Email: elemon@chmca.org
-
Principal Investigator:
- Ana Frabotta, PNP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pediatric patients <18
- Evaluated for hypergranulation at the G-tube site
- Inpatient and out-patient
Exclusion Criteria:
Children not meeting the above criteia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.
|
Silver Nitrate Sticks
|
Active Comparator: Group 2
Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver.
|
0.5% cream
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal reduction in granulation tissue
Time Frame: During maximum of 4 weeks of therapy
|
During maximum of 4 weeks of therapy
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150110
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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