Design of a Dressing for Gastrostomy Buttons in Pediatric Population

Completed · Not applicable

Conditions studied: Gastrostomy Complications

In brief

Gastrostomy tube (G-tube) complications, such as granulation tissue formation and tube dislodgements, are frequent causes of emergency department visits. The investigators have developed two G-tube dressing designs using commercially available materials and products to decrease the risk of G-tube related complications. The investigators aim in this study is to pilot two novel G-tube dressings in patients with pre-existing G-tubes to gain parental feedback on device designs, ease of use and G-tube stability in preparation for a final design and trial. Based on the feedback, further iterations will be developed and trialed in eligible study subjects.

Key facts

Study ID

NCT03142750

Run by

University of Colorado, Denver

People needed

24

Starts

2017-09-01

Expected to finish

2018-08-30

Last updated by the study team

2020-01-18

Who can join

Age: 0 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a pre-existing a G-tube
• Patients presenting to the G-tube or surgery clinic for G-tube replacement at Children's Hospital, Aurora, Colorado.
• Patients admitted to the hospital with a pre-existing G-tube for reasons unrelated to the G-tube will be eligible for the study if they have issues with the G-tube site.

You may not qualify if…

• Refusal to participate
• Those with other types of gastrostomy tubes (other than Mini Balloon Button)
• Those whose parents or legal guardians cannot be reached by telephone
• Prisoners
• Pregnant women
• Decisionally challenged subjects

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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