Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519738
Recruitment Status : Recruiting
First Posted : August 11, 2015
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ronald Bruce Hirschl, MD, University of Michigan

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 soapcloth 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2020


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Sarah Fox, BA, CCRP 734-232-8005 sarasort@med.umich.edu

Locations
Layout table for location information
United States, Michigan
C.S. Mott Children's Hospital, University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Ronald B Hirschl, MD Univeristy of Michigan

Layout table for additonal information
Responsible Party: Ronald Bruce Hirschl, MD, Professor of Pediatric Surgery & Head, Department of Pediatric Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT02519738     History of Changes
Other Study ID Numbers: HUM00077762
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Silver Nitrate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents