Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

• Sponsor: University of Michigan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02519738
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 3
• Actual Duration (Months): 45.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Other Abnormal Granulation Tissue Nos	Drug: Silver Nitrate; Drug: Kenalog (Triamcinolone); Other: Washcloth Abrasion	Phase 3

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 soap cloth 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Jan 15, 2015
• Actual Primary Completion Date: Nov 13, 2018
• Actual Study Completion Date: Nov 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Decrease in Size (mm) of Granulation Tissue [8 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Any patient falling within age group with granulation tissue around G tube site

Exclusion Criteria:

• Patients falling outside of age group range

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	C.S. Mott Children's Hospital, University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Ronald B Hirschl, MD, Univeristy of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 12, 2021

More Information

Publications

None provided.

• Responsible Party: Ronald Bruce Hirschl, MD, Professor of Pediatric Surgery & Head, Department of Pediatric Surgery, University of Michigan
• ClinicalTrials.gov Identifier: NCT02519738
• Other Study ID Numbers: HUM00077762
• First Posted: Aug 11, 2015
• Last Update Posted: Jan 25, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Silver Nitrate; Triamcinolone; Triamcinolone Acetonide

Study Results

Participant Flow

Arm/Group Title	Silver Nitrate	Kenalog (Triamcinolone)	Washcloth Abrasion
Arm/Group Description	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 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 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.
Period Title: Overall Study
STARTED	20	17	15
COMPLETED	6	4	3
NOT COMPLETED	14	13	12

Baseline Characteristics

Arm/Group Title	Silver Nitrate	Kenalog (Triamcinolone)	Washcloth Abrasion	Total
Arm/Group Description	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 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 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 of all reporting groups
Overall Participants	20	17	15	52
Age, Customized (years) [Mean (Full Range) ]
Age in years	5.38	3.39	6.47	5.04
Sex: Female, Male (Count of Participants)
Female	6 30%	6 35.3%	8 53.3%	20 38.5%
Male	14 70%	11 64.7%	7 46.7%	32 61.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 5%	0 0%	0 0%	1 1.9%
Asian	0 0%	2 11.8%	0 0%	2 3.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	5 25%	1 5.9%	0 0%	6 11.5%
White	12 60%	11 64.7%	13 86.7%	36 69.2%
More than one race	2 10%	0 0%	0 0%	2 3.8%
Unknown or Not Reported	0 0%	3 17.6%	2 13.3%	5 9.6%
Region of Enrollment (participants) [Number]
United States	20 100%	17 100%	15 100%	52 100%

Outcome Measures

1. Primary Outcome

Title	Decrease in Size (mm) of Granulation Tissue
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Population consists of those participants for whom pre and 8 week data is available.

Arm/Group Title	Silver Nitrate	Kenalog (Triamcinolone)	Washcloth Abrasion
Arm/Group Description	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 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 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.
Measure Participants	7	4	4
Pre-Treatment	101.12 (138.60)	83.14 (13.08)	121.72 (71.26)
Post-Treatment	22.36 (52.94)	45.06 (21)	140.54 (96.51)
Change from pre-post	78.77 (149.10)	37.95 (31.62)	-18.81 (106.58)

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Silver Nitrate		Kenalog (Triamcinolone)		Washcloth Abrasion
Arm/Group Description	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 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 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.
All Cause Mortality
	Silver Nitrate		Kenalog (Triamcinolone)		Washcloth Abrasion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		1/17 (5.9%)		1/15 (6.7%)
Serious Adverse Events
	Silver Nitrate		Kenalog (Triamcinolone)		Washcloth Abrasion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/17 (0%)		1/15 (6.7%)
Blood and lymphatic system disorders
Neutropenia	0/20 (0%)		0/17 (0%)		1/15 (6.7%)
Other (Not Including Serious) Adverse Events
	Silver Nitrate		Kenalog (Triamcinolone)		Washcloth Abrasion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/20 (30%)		4/17 (23.5%)		4/15 (26.7%)
Infections and infestations
abscess at site	0/20 (0%)		0/17 (0%)		1/15 (6.7%)
infection at G tube site	0/20 (0%)		1/17 (5.9%)		0/15 (0%)
Injury, poisoning and procedural complications
dislodged G tube	1/20 (5%)		0/17 (0%)		0/15 (0%)
Skin and subcutaneous tissue disorders
Pain with Rx/burning	4/20 (20%)		1/17 (5.9%)		1/15 (6.7%)
bleeding at site	0/20 (0%)		0/17 (0%)		1/15 (6.7%)
worsening granulation	0/20 (0%)		1/17 (5.9%)		1/15 (6.7%)
irritation/inflammation at G tube site	1/20 (5%)		1/17 (5.9%)		0/15 (0%)

Limitations/Caveats

Because evaluable data was less than 1/4 of what was sought, no statistical power was achieved.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.