Ann Arbor, Michigan 48109


Purpose:

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.


Study summary:

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 soapcloth 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.


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


NCT ID:

NCT02519738


Primary Contact:

Principal Investigator
Ronald B Hirschl, MD
Univeristy of Michigan

Tina Thomas, MBBS
Phone: 734-320-7568
Email: tinath@med.umich.edu


Backup Contact:

Email: amehring@umich.edu
Ann Mehringer, MS CCRC
Phone: 734-232-8005


Location Contact:

Ann Arbor, Michigan 48109
United States



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Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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