Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

NCT ID: NCT02519738

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-15
• Study Completion Date: 2018-11-13

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.

Conditions

Other Abnormal Granulation Tissue Nos

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Silver Nitrate

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Kenalog (Triamcinolone)

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Washcloth Abrasion

Intervention Type: OTHER

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

Interventions

Silver Nitrate

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

Intervention Type: DRUG

Kenalog (Triamcinolone)

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

Intervention Type: DRUG

Washcloth Abrasion

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients falling outside of age group range

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Ronald Bruce Hirschl, MD

Professor of Pediatric Surgery & Head, Department of Pediatric Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald B Hirschl, MD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Michigan

Locations

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

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00077762

Identifier Type: -

Identifier Source: org_study_id