Clinical Trial of Gastrostomy Button Securement Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2024-11-01

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).

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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.

Conditions

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Gastrostomy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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G-button Securement Device

Subjects will be provided instructions and a 12-week supply of test devices, sufficient to change the gauze dressing at least once per day.

Group Type OTHER

Button Huggie

Intervention Type DEVICE

low profile, external securement device for G-buttons

Standard Dressing

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Button Huggie

low profile, external securement device for G-buttons

Intervention Type DEVICE

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No