Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

Phase 3

Terminated

• Conditions: Other Abnormal Granulation Tissue Nos
• Interventions: Drug: Kenalog (Triamcinolone); Other: Washcloth Abrasion; Drug: Silver Nitrate

• Registration Number: NCT02519738
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-01-15
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-08-08
• Study First Posted: 2015-08-11
• Primary Completion: 2018-11-13
• Study Completion: 2018-11-13
• Disposition First Submitted: 2020-12-22
• Disposition First Submitted QC: 2021-01-12
• Disposition First Posted: 2021-01-14
• Status Verified: 2021-12
• Results First Submitted: 2021-12-28
• Results First Submitted QC: 2021-12-28
• Last Update Submitted: 2021-12-28
• Results First Posted: 2022-01-25
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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Exclusion Criteria

• Patients falling outside of age group range

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kenalog (Triamcinolone)	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.
Washcloth Abrasion	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.
Silver Nitrate	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.

Primary Outcome Measures

Name	Time	Method
Decrease in Size (mm) of Granulation Tissue	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.

Trial Locations

Locations (1)

C.S. Mott Children's Hospital, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States