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

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.
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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.
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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.
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Other: Washcloth Abrasion
Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks. |
- 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.

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Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Any patient falling within age group with granulation tissue around G tube site
Exclusion Criteria:
- Patients falling outside of age group range

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
United States, Michigan | |
C.S. Mott Children's Hospital, University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Ronald B Hirschl, MD | Univeristy of Michigan |
Documents provided by Ronald Bruce Hirschl, MD, University of Michigan:
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |