Gastrostomy Complications
Conditions
Keywords
Gastrostomy
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.
Interventions
DEVICEButton Huggie
low profile, external securement device for G-buttons
Sponsors
University of Colorado, Denver
Phoenix Children's Hospital
Stanford University
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 31 days to 18 years old who present for surgical placement of a gastrostomy button (open, endoscopically, or laparoscopically). * Patient weight is ≥ 4kg.
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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in G-button complications | entire study (3 months after placement) | leakage, dislodgment, granulation tissue formation, and skin infection/irriation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Strain Index | entire study (3 months after placement) | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteve Moulton, MD
University of Colorado, Denver
Outcome results
None listed