Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

December 28, 2021 updated by: Ronald Bruce Hirschl, MD, University of Michigan

Granulation Tissue at G Tube Site: Treatment With Kenalog vs Chemical Cauterization With Silver Nitrate vs Soap Washcloth Abrasion

Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common problem seen in the pediatric surgery population. There is no standard treatment that has been identified in clinical practice to treat granulation tissue effectively. Clinicians prescribe treatments of varying nature to help treat this condition. By conducting this study, the investigators hope to identify if there is any difference in the treatment groups and if there is any superiority for one treatment over the other. The three arms in the study are Silver Nitrate treatment, treatment with Kenalog, and Washcloth abrasion. Treatments will continue over a period of three weeks, and the progress will be followed using surveys and photographs.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Hypergranulation tissue surrounding gastrostomy tube sites in pediatric patients is a significant problem. This tissue may cause drainage or bleeding that bothers patients and parents. Numerous methods of treatment are used for treatment of hypergranulation tissue, but no data exists to support one method of treatment over another. The investigators plan to perform a prospective randomized trial of three different therapies (silver nitrate cauterization, topical kenalog, and soap cloth abrasion) to identify the best treatment modality. Participants will be followed via office visit at four and eight weeks after initiation of therapy. Measurements of the granulation tissue and photographs will be obtained pre treatment and at each post treatment visit. In addition parents will be asked to fill out a pre and post treatment survey regarding improvement in symptoms. Investigators plan to enroll 120 patients total with the intention of having 40 participants in each group.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

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
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • C.S. MOTT Children's Hospital, University of Michigan

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 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient falling within age group with granulation tissue around G tube site

Exclusion Criteria:

  • Patients falling outside of age group range

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: Silver Nitrate
Silver Nitrate is supplied in the form of pre-packaged applicator sticks to parents and patients. The concentration is 75% Silver Nitrate and 25% Potassium Nitrate. Application will be done 3 times a week for a period of 3 weeks.
Drug: Silver Nitrate
Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
Active Comparator: Kenalog (Triamcinolone)
Kenalog is a topical corticosteroid that shares anti-inflammatory, anti-pruritic, and vasoconstrictive actions.The dosage of Kenalog used in the study is 0.5%. Application is topical, and the frequency is 3 times a day for the 3 week trial period. FDA approved use of Kenalog in the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It has not been studied whether Kenalog has any proven advantage over Silver nitrate in the treatment of granulation tissue, but it has been used for the treatment of granulation tissue at the gastrostomy site with good effect.
Drug: Kenalog (Triamcinolone)
Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
Active Comparator: Washcloth Abrasion
Washcloth abrasion will be done with regular soap and water applied to a washcloth. The granulation tissue will be gently washed and abraded once daily for three weeks.
Other: Washcloth Abrasion
Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in Size (mm) of Granulation Tissue
Time Frame: 8 weeks
Measurements are calculated from photographs taken with a millimeter ruler next to granulation tissue on a horizontal plane and a vertical plane. The horizontal and vertical diameters are averaged and then halved, to give a radius which is squared and multiplied by Pi for an approximate area. The area at 8 weeks is subtracted from the area at baseline, to calculate the change and then they are averaged across the individuals with pre and post data for the arm. This approximation is limited by the fact that the shape and all the dimensions of the granulation tissue are highly variable. In order to measure the change the horizontal and vertical diameters were averaged as if they were a circle. This is a limitation of the analysis.
8 weeks

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Ronald B Hirschl, MD, Univeristy of Michigan

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 (Actual)

January 15, 2015

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

November 13, 2018

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

August 8, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

December 28, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00077762

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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