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Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

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ClinicalTrials.gov Identifier: NCT02519738
Recruitment Status : Terminated (enrollment difficulties)
First Posted : August 11, 2015
Results First Posted : January 25, 2022
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Ronald Bruce Hirschl, MD, University of Michigan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Other Abnormal Granulation Tissue Nos Drug: Silver Nitrate Drug: Kenalog (Triamcinolone) Other: Washcloth Abrasion Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Granulation Tissue at G Tube Site: Treatment With Kenalog vs Chemical Cauterization With Silver Nitrate vs Soap Washcloth Abrasion
Actual Study Start Date : January 15, 2015
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : November 13, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients falling outside of age group range
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519738


Locations
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United States, Michigan
C.S. Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Ronald B Hirschl, MD Univeristy of Michigan
  Study Documents (Full-Text)

Documents provided by Ronald Bruce Hirschl, MD, University of Michigan:
Study Protocol and Statistical Analysis Plan  [PDF] November 12, 2021

More Information
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Responsible Party: Ronald Bruce Hirschl, MD, Professor of Pediatric Surgery & Head, Department of Pediatric Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT02519738    
Other Study ID Numbers: HUM00077762
First Posted: August 11, 2015    Key Record Dates
Results First Posted: January 25, 2022
Last Update Posted: January 25, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Silver Nitrate
Triamcinolone
Triamcinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Anti-Infective Agents, Local
Anti-Infective Agents