Recruiting

Silver Nitrate & Topical Corticosteroids

Sponsor:

Akron Children's Hospital

Code:

NCT02398539

Conditions

Hypergranulation Tissue; Gastrostomy Tube Site

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Silver Nitrate

Triamcinolone

Study Details

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.

Conditions

Hypergranulation Tissue; Gastrostomy Tube Site

Study ID

NCT02398539

Start date

Apr, 2015

Status verified date

May, 2015

Completion date

Apr, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1

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

active comparator: Group 2

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

Interventions

Silver Nitrate

Silver Nitrate Sticks

Triamcinolone

0.5% cream

Primary outcome measure

  • Maximal reduction in granulation tissue [ Time Frame: During maximum of 4 weeks of therapy ]

Central Contacts and Locations

Central contacts

Eloise Lemon, MSN, MHA, RN

(330) 543-3193ELEMON@CHMCA.ORG

Locations

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Contacts

Eloise Lemon

330-543-3193elemon@chmca.org

Principal Investigator:

Ana Frabotta, PNP

More Information

Sponsor

Akron Children's Hospital

Last update posted

May 29, 2015

Last verified

May, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Akron Children's Hospital on 2015-05-29.