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Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

NCT02519738 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-01-25

Study results available
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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

Interventions

DRUG

Silver Nitrate

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

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Ronald B Hirschl, MD · Univeristy of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-15
Primary Completion
2018-11-13
Completion
2018-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02519738 on ClinicalTrials.gov