Other Abnormal Granulation Tissue Nos
Conditions
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.
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.
Interventions
DRUGSilver Nitrate
Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
OTHERWashcloth Abrasion
Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 17 |
| 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. | 15 |
| Total | 52 |
Baseline characteristics
| Characteristic | Silver Nitrate | Total | Washcloth Abrasion | Kenalog (Triamcinolone) |
|---|---|---|---|---|
| Age, Customized Age in years | 5.38 years | 5.04 years | 6.47 years | 3.39 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 12 Participants | 36 Participants | 13 Participants | 11 Participants |
| Region of Enrollment United States | 20 participants | 52 participants | 15 participants | 17 participants |
| Sex: Female, Male Female | 6 Participants | 20 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Male | 14 Participants | 32 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 1 / 17 | 1 / 15 |
| other Total, other adverse events | 6 / 20 | 4 / 17 | 4 / 15 |
| serious Total, serious adverse events | 0 / 20 | 0 / 17 | 1 / 15 |
Outcome results
Primary
Decrease in Size (mm) of Granulation Tissue
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
Population: Population consists of those participants for whom pre and 8 week data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silver Nitrate | Decrease in Size (mm) of Granulation Tissue | Post-Treatment | 22.36 mm^2 | Standard Deviation 52.94 |
| Silver Nitrate | Decrease in Size (mm) of Granulation Tissue | Pre-Treatment | 101.12 mm^2 | Standard Deviation 138.6 |
| Silver Nitrate | Decrease in Size (mm) of Granulation Tissue | Change from pre-post | 78.77 mm^2 | Standard Deviation 149.1 |
| Kenalog (Triamcinolone) | Decrease in Size (mm) of Granulation Tissue | Post-Treatment | 45.06 mm^2 | Standard Deviation 21 |
| Kenalog (Triamcinolone) | Decrease in Size (mm) of Granulation Tissue | Pre-Treatment | 83.14 mm^2 | Standard Deviation 13.08 |
| Kenalog (Triamcinolone) | Decrease in Size (mm) of Granulation Tissue | Change from pre-post | 37.95 mm^2 | Standard Deviation 31.62 |
| Washcloth Abrasion | Decrease in Size (mm) of Granulation Tissue | Pre-Treatment | 121.72 mm^2 | Standard Deviation 71.26 |
| Washcloth Abrasion | Decrease in Size (mm) of Granulation Tissue | Change from pre-post | -18.81 mm^2 | Standard Deviation 106.58 |
| Washcloth Abrasion | Decrease in Size (mm) of Granulation Tissue | Post-Treatment | 140.54 mm^2 | Standard Deviation 96.51 |