Clinical trial NCT04001946: Clinical Trial of Gastrostomy Button Securement Device
Official title: Clinical Trial of Gastrostomy Button Securement Device
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gastrostomy Complications
Keywords: Gastrostomy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Phoenix Children's Hospital
name: Stanford University
name: University of Utah
First posted: 2019-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in G-button complications
timeFrame: entire study (3 months after placement)
Secondary outcomes:
measure: Caregiver Strain Index
timeFrame: entire study (3 months after placement)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's
state: Arizona
city: Palo Alto
country: United States
facility: Stanford Lucile Packard Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Colorado, Denver
name: Steve Moulton, MD
role: PRINCIPAL_INVESTIGATOR
References: