Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue
|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Maximal reduction in granulation tissue [ Time Frame: During maximum of 4 weeks of therapy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398539
|Contact: Eloise Lemon, MSN, MHA, RN||(330) 543-3193||ELEMON@CHMCA.ORG|
|United States, Ohio|
|Akron Children's Hospital||Recruiting|
|Akron, Ohio, United States, 44308|
|Contact: Eloise Lemon 330-543-3193 firstname.lastname@example.org|
|Principal Investigator: Ana Frabotta, PNP|