Randomized Clinical Trial Comparing Silver Nitrate Application With Topical Corticosteroids for Hypergranulation Tissue at Gastrostomy Sites
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Akron Children's Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Maximal reduction in granulation tissue
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.
Intervention: Silver Nitrate (Drug)
Group 2
Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver.
Intervention: Triamcinolone (Drug)
Outcomes
Primary Outcomes
Maximal reduction in granulation tissue
Time Frame: During maximum of 4 weeks of therapy
Secondary Outcomes
No secondary outcomes reported
Investigators
Eloise Lemon
Principal Investigator
Akron Children's Hospital