Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue

Phase 4

• Conditions: Hypergranulation Tissue; Gastrostomy Tube Site
• Interventions: Drug: Silver Nitrate; Drug: Triamcinolone

• Registration Number: NCT02398539
• Lead Sponsor: Akron Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-25
• Study Start: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29
• Primary Completion: 2015-12
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Pediatric patients <18
2. Evaluated for hypergranulation at the G-tube site
3. Inpatient and out-patient

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Exclusion Criteria

Children not meeting the above criteia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Silver Nitrate	Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.
Group 2	Triamcinolone	Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver.

Primary Outcome Measures

Name	Time	Method
Maximal reduction in granulation tissue	During maximum of 4 weeks of therapy

Trial Locations

Locations (1)

Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States