Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

Other Abnormal Granulation Tissue Nos Clinical Trial

Official title:

Granulation Tissue at G Tube Site: Treatment With Kenalog vs Chemical Cauterization With Silver Nitrate vs Soap Washcloth Abrasion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02519738
• Other study ID #: HUM00077762
• Status: Terminated
• Phase: Phase 3
• Start date: January 15, 2015
• Est. completion date: November 13, 2018

Study information

• Verified date: December 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: November 13, 2018
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients falling outside of age group range

Related Conditions & MeSH terms

• Other Abnormal Granulation Tissue Nos

Intervention

Drug:
• Silver Nitrate
Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
• 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.

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital, University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Size (mm) of Granulation Tissue	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.	8 weeks