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Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Other Abnormal Granulation Tissue Nos

Intervention: Silver Nitrate (Drug); Kenalog (Triamcinolone) (Drug); Washcloth Abrasion (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Michigan

Official(s) and/or principal investigator(s):
Ronald B Hirschl, MD, Principal Investigator, Affiliation: Univeristy of Michigan

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Decrease in size (mm) of granulation tissue

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 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.

Eligibility

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

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

C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, Michigan 48109, United States; Recruiting
Additional Information

Starting date: January 2015
Last updated: August 8, 2015

Page last updated: August 23, 2015

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