Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue

Akron Children's Hospital

Status and phase: Unknown; Phase 4

Conditions: Hypergranulation Tissue; Gastrostomy Tube Site

Treatments: Drug: Silver Nitrate; Drug: Triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02398539

150110

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Children not meeting the above criteia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.

Treatment:

Drug: Silver Nitrate

Group 2

Active Comparator group

Description:

Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver.

Treatment:

Drug: Triamcinolone