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Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02398539
Recruitment Status : Unknown
Verified May 2015 by Eloise Lemon, Akron Children's Hospital.
Recruitment status was:  Recruiting
First Posted : March 25, 2015
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Eloise Lemon, Akron Children's Hospital

Brief Summary:

This protocol describes a randomized, two arm clinical trial comparing two topical treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are randomized to either group 1or group 2 treatments:

Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at the discretion of the investigator or if there is resolution of the of the hypergranulation tissue.

Condition or disease Intervention/treatment Phase
Hypergranulation Tissue; Gastrostomy Tube Site Drug: Silver Nitrate Drug: Triamcinolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Silver Nitrate Application With Topical Corticosteroids for Hypergranulation Tissue at Gastrostomy Sites
Study Start Date : April 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group 1
Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.
Drug: Silver Nitrate
Silver Nitrate Sticks

Active Comparator: Group 2
Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver.
Drug: Triamcinolone
0.5% cream

Primary Outcome Measures :
  1. Maximal reduction in granulation tissue [ Time Frame: During maximum of 4 weeks of therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Pediatric patients <18
  2. Evaluated for hypergranulation at the G-tube site
  3. Inpatient and out-patient

Exclusion Criteria:

Children not meeting the above criteia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02398539

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Contact: Eloise Lemon, MSN, MHA, RN (330) 543-3193 ELEMON@CHMCA.ORG

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United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Eloise Lemon    330-543-3193   
Principal Investigator: Ana Frabotta, PNP         
Sponsors and Collaborators
Akron Children's Hospital

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Responsible Party: Eloise Lemon, Principal Investigator, Akron Children's Hospital Identifier: NCT02398539     History of Changes
Other Study ID Numbers: 150110
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Silver Nitrate
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents