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
1 other identifier
interventional
50
1 country
1
Brief 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. However, the therapy may be discontinued anytime at the discretion of the investigator or if there is resolution of the of the hypergranulation tissue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 29, 2015
May 1, 2015
8 months
March 20, 2015
May 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Maximal reduction in granulation tissue
During maximum of 4 weeks of therapy
Study Arms (2)
Group 1
ACTIVE COMPARATORSilver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.
Group 2
ACTIVE COMPARATORTriamcinolone cream, 0.5% applied three times per day by the patient's caregiver.
Interventions
Eligibility Criteria
You may qualify if:
- Pediatric patients \<18
- Evaluated for hypergranulation at the G-tube site
- Inpatient and out-patient
You may not qualify if:
- Children not meeting the above criteia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akron Children's Hospital
Akron, Ohio, 44308, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 20, 2015
First Posted
March 25, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
May 29, 2015
Record last verified: 2015-05