Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue

May 28, 2015 updated by: Eloise Lemon, Akron Children's Hospital

Randomized Clinical Trial Comparing Silver Nitrate Application With Topical Corticosteroids for Hypergranulation Tissue at Gastrostomy Sites

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Akron Children's Hospital
        • Contact:
        • Principal Investigator:
          • Ana Frabotta, PNP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.
Drug: Silver Nitrate
Silver Nitrate Sticks
Active Comparator: Group 2
Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver.
Drug: Triamcinolone
0.5% cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal reduction in granulation tissue
Time Frame: During maximum of 4 weeks of therapy
During maximum of 4 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akron Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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