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Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

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ClinicalTrials.gov Identifier: NCT02519738
Recruitment Status : Recruiting
First Posted : August 11, 2015
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ronald Bruce Hirschl, MD, University of Michigan

Tracking Information
First Submitted Date  ICMJE July 22, 2015
First Posted Date  ICMJE August 11, 2015
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE January 15, 2015
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion
Official Title  ICMJE Granulation Tissue at G Tube Site: Treatment With Kenalog vs Chemical Cauterization With Silver Nitrate vs Soap Washcloth Abrasion
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Other Abnormal Granulation Tissue Nos
Intervention  ICMJE
  • Drug: Silver Nitrate
    Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
  • Drug: Kenalog (Triamcinolone)
    Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
  • Other: Washcloth Abrasion
    Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Silver Nitrate
  • 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.
    Intervention: Drug: Kenalog (Triamcinolone)
  • 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.
    Intervention: Other: Washcloth Abrasion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients falling outside of age group range
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sarah Fox, BA, CCRP 734-232-8005 sarasort@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02519738
Other Study ID Numbers  ICMJE HUM00077762
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronald Bruce Hirschl, MD, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ronald B Hirschl, MD Univeristy of Michigan
PRS Account University of Michigan
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP