Trial Outcomes & Findings for Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion (NCT NCT02519738)
NCT ID: NCT02519738
Last Updated: 2022-01-25
Results Overview
Measurements are calculated from photographs taken with a millimeter ruler next to granulation tissue on a horizontal plane and a vertical plane. The horizontal and vertical diameters are averaged and then halved, to give a radius which is squared and multiplied by Pi for an approximate area. The area at 8 weeks is subtracted from the area at baseline, to calculate the change and then they are averaged across the individuals with pre and post data for the arm. This approximation is limited by the fact that the shape and all the dimensions of the granulation tissue are highly variable. In order to measure the change the horizontal and vertical diameters were averaged as if they were a circle. This is a limitation of the analysis.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
8 weeks
Results posted on
2022-01-25
Participant Flow
Participant milestones
| Measure |
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.
Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
|
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.
Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
|
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.
Washcloth Abrasion: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
15
|
|
Overall Study
COMPLETED
|
6
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion
Baseline characteristics by cohort
| Measure |
Silver Nitrate
n=20 Participants
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.
Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
|
Kenalog (Triamcinolone)
n=17 Participants
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.
Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
|
Washcloth Abrasion
n=15 Participants
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.
Washcloth Abrasion: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age in years
|
5.38 years
n=99 Participants
|
3.39 years
n=107 Participants
|
6.47 years
n=206 Participants
|
5.04 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
17 participants
n=107 Participants
|
15 participants
n=206 Participants
|
52 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Population consists of those participants for whom pre and 8 week data is available.
Measurements are calculated from photographs taken with a millimeter ruler next to granulation tissue on a horizontal plane and a vertical plane. The horizontal and vertical diameters are averaged and then halved, to give a radius which is squared and multiplied by Pi for an approximate area. The area at 8 weeks is subtracted from the area at baseline, to calculate the change and then they are averaged across the individuals with pre and post data for the arm. This approximation is limited by the fact that the shape and all the dimensions of the granulation tissue are highly variable. In order to measure the change the horizontal and vertical diameters were averaged as if they were a circle. This is a limitation of the analysis.
Outcome measures
| Measure |
Silver Nitrate
n=7 Participants
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.
Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
|
Kenalog (Triamcinolone)
n=4 Participants
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.
Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
|
Washcloth Abrasion
n=4 Participants
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.
Washcloth Abrasion: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
|
|---|---|---|---|
|
Decrease in Size (mm) of Granulation Tissue
Pre-Treatment
|
101.12 mm^2
Standard Deviation 138.60
|
83.14 mm^2
Standard Deviation 13.08
|
121.72 mm^2
Standard Deviation 71.26
|
|
Decrease in Size (mm) of Granulation Tissue
Post-Treatment
|
22.36 mm^2
Standard Deviation 52.94
|
45.06 mm^2
Standard Deviation 21
|
140.54 mm^2
Standard Deviation 96.51
|
|
Decrease in Size (mm) of Granulation Tissue
Change from pre-post
|
78.77 mm^2
Standard Deviation 149.10
|
37.95 mm^2
Standard Deviation 31.62
|
-18.81 mm^2
Standard Deviation 106.58
|
Adverse Events
Silver Nitrate
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Kenalog (Triamcinolone)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Washcloth Abrasion
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Silver Nitrate
n=20 participants at risk
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.
Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
|
Kenalog (Triamcinolone)
n=17 participants at risk
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.
Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
|
Washcloth Abrasion
n=15 participants at risk
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.
Washcloth Abrasion: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20 • 8 weeks
|
0.00%
0/17 • 8 weeks
|
6.7%
1/15 • 8 weeks
|
Other adverse events
| Measure |
Silver Nitrate
n=20 participants at risk
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.
Silver Nitrate: Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
|
Kenalog (Triamcinolone)
n=17 participants at risk
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.
Kenalog (Triamcinolone): Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
|
Washcloth Abrasion
n=15 participants at risk
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.
Washcloth Abrasion: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain with Rx/burning
|
20.0%
4/20 • 8 weeks
|
5.9%
1/17 • 8 weeks
|
6.7%
1/15 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
bleeding at site
|
0.00%
0/20 • 8 weeks
|
0.00%
0/17 • 8 weeks
|
6.7%
1/15 • 8 weeks
|
|
Infections and infestations
abscess at site
|
0.00%
0/20 • 8 weeks
|
0.00%
0/17 • 8 weeks
|
6.7%
1/15 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
worsening granulation
|
0.00%
0/20 • 8 weeks
|
5.9%
1/17 • 8 weeks
|
6.7%
1/15 • 8 weeks
|
|
Infections and infestations
infection at G tube site
|
0.00%
0/20 • 8 weeks
|
5.9%
1/17 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
irritation/inflammation at G tube site
|
5.0%
1/20 • 8 weeks
|
5.9%
1/17 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
|
Injury, poisoning and procedural complications
dislodged G tube
|
5.0%
1/20 • 8 weeks
|
0.00%
0/17 • 8 weeks
|
0.00%
0/15 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place