CompletedNot Applicable

Design of a Dressing for Gastrostomy Buttons in Pediatric Population

United States24 participantsStarted 2017-09-01

Plain-language summary

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.

Who can participate

Age range31 Days – 25 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

What they're measuring

Number of Participants Satisfied With Current Dressings

Timeframe: Baseline

Number of Participants Satisfied With Experimental Dressings

Timeframe: 1 Week

Trial details

NCT IDNCT03142750

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-15

Results submitted2019-10-11