Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

NCT02519738 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: HUM00077762
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Abnormal Granulation Tissue Nos

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Silver Nitrate

ACTIVE COMPARATOR

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

Kenalog (Triamcinolone)

ACTIVE COMPARATOR

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)

Washcloth Abrasion

ACTIVE COMPARATOR

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

Interventions

Silver Nitrate DRUG

Silver nitrate to be applied 3 times weekly for a period of 3 weeks.

Silver Nitrate

Kenalog (Triamcinolone) DRUG

Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.

Kenalog (Triamcinolone)

Washcloth Abrasion OTHER

Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.

Washcloth Abrasion

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Patients falling outside of age group range

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

C.S. Mott Children's Hospital, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Silver Nitrate; Triamcinolone Acetonide; Triamcinolone

Intervention Hierarchy (Ancestors)

Nitrates; Nitric Acid; Nitrogen Compounds; Inorganic Chemicals; Silver Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Because evaluable data was less than 1/4 of what was sought, no statistical power was achieved.

Results Point of Contact

• Title: Ron Hirschl
• Organization: University of Michigan

rhirschl@med.umich.edu

734 764-6482

Study Officials

• Ronald B Hirschl, MD

  Univeristy of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Surgery & Head, Department of Pediatric Surgery

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: August 11, 2015
• Study Start: January 15, 2015
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: January 25, 2022
• Results First Posted: January 25, 2022

Record last verified: 2021-12

Locations

US (1)