Clinical Trial of Gastrostomy Button Securement Device

Study Overview
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Brief Summary
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Gastrostomy button (G-button) complications, such as granulation tissue formation, tube dislodgements, leakage, skin irritation or infection are frequent causes of post-operative clinic and emergency department visits. The investigators have developed a G-button securement device that they believe will have a significant reduction in the complications listed above. The investigators plan to randomized 200 patients to either the new securement device (treatment group) or the standard dressing (control group).

Detailed Description
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Gastrostomy button (G-button) is a small tube inserted into the stomach that is used to feed and provide medication to children who can not eat or take medication on their own. G-buttons are commonly placed through surgery. While G-buttons give access for caregivers to provide adequate nutrition, they also can have complications associated with them; including, but not limited to leakage, skin irritation or infection, and dislodgement. These complications can be a big burden for caregivers and medical providers causing extra clinic, ED visits, and increased cost. The investigators have designed a securement device for the gastrostomy button and want to compare the device to the standard securement method, which is tape and gauze dressing. The investigators believe that they will show a significant reduction in the complications listed above. The investigators plan to randomized 200 patients to either the new securement device (treatment group) or the standard dressing (control group). The investigators plan to get feedback from caregivers at 4, 8, and 12 weeks. The G-button securement device that is a Class II, 510(k) exempt medical device, subject to General Controls under Product Code PLI, regulated by 21 CFR 876.5980.

Official Title
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Clinical Trial of Gastrostomy Button Securement Device

Conditions
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Gastrostomy Complications

Intervention / Treatment
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* Device: Button Huggie


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 31 days to 18 years old who present for surgical placement of a gastrostomy button (open, endoscopically, or laparoscopically). Any patient with a pre-existing G-button who presents to the G-button or surgery clinic for G-button replacement or have complications associated with the G-button at any of study site locations. Patients admitted to the hospital with a pre-existing G-button for reasons unrelated to the G-button will be eligible for the study if they have complications with their current G-button site. Exclusion Criteria: Refusal who object at any time to participate in the study Those whose parents or legal guardians cannot be reached by telephone Prisoners Pregnant women Impaired decision making capacity

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: G-button Securement Device<br>Subjects will be provided instructions and a 12-week supply of test devices, sufficient to change the gauze dressing at least once per day. | Device: Button Huggie<br>* low profile, external securement device for G-buttons<br>|
| No Intervention: Standard Dressing<br>Subjects will be provided instructions and a 12-week supply of tape and gauze (current standard of care), sufficient to change the gauze dressing at least once per day. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in G-button complications | leakage, dislodgment, granulation tissue formation, and skin infection/irriation | entire study (3 months after placement) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Strain Index | Obtain feedback from parents and patients at four, eight, and twelve weeks on various aspects of the securement device Comfort, quality of materials, adhesiveness, ease of use, types and number of interactions with healthcare providers (phone calls, ED, and clinic visits) | entire study (3 months after placement) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrostomy