Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02519738|
Recruitment Status : Recruiting
First Posted : August 11, 2015
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Other Abnormal Granulation Tissue Nos||Drug: Silver Nitrate Drug: Kenalog (Triamcinolone) Other: Washcloth Abrasion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Granulation Tissue at G Tube Site: Treatment With Kenalog vs Chemical Cauterization With Silver Nitrate vs Soap Washcloth Abrasion|
|Actual Study Start Date :||January 15, 2015|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||November 2020|
Active Comparator: Silver Nitrate
Silver Nitrate is supplied in the form of pre-packaged applicator sticks to parents and patients. The concentration is 75% Silver Nitrate and 25% Potassium Nitrate. Application will be done 3 times a week for a period of 3 weeks.
Drug: Silver Nitrate
Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
Active Comparator: Kenalog (Triamcinolone)
Kenalog is a topical corticosteroid that shares anti-inflammatory, anti-pruritic, and vasoconstrictive actions.The dosage of Kenalog used in the study is 0.5%. Application is topical, and the frequency is 3 times a day for the 3 week trial period. FDA approved use of Kenalog in the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It has not been studied whether Kenalog has any proven advantage over Silver nitrate in the treatment of granulation tissue, but it has been used for the treatment of granulation tissue at the gastrostomy site with good effect.
Drug: Kenalog (Triamcinolone)
Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
Active Comparator: Washcloth Abrasion
Washcloth abrasion will be done with regular soap and water applied to a washcloth. The granulation tissue will be gently washed and abraded once daily for three weeks.
Other: Washcloth Abrasion
Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
- Decrease in size (mm) of granulation tissue [ Time Frame: 8 weeks ]Measurements are calculated from photographs taken with a millimeter ruler next to granulation tissue on a horizontal plane and a vertical plane.
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 ClinicalTrials.gov identifier (NCT number): NCT02519738
|Contact: Sarah Fox, BA, CCRPemail@example.com|
|United States, Michigan|
|C.S. Mott Children's Hospital, University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Ronald B Hirschl, MD||Univeristy of Michigan|