N/A Completed N=24 Other

Design of a Dressing for Gastrostomy Buttons in Pediatric Population

Gastrostomy Complications

Source: ClinicalTrials.gov NCT03142750 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcomePrimary: Number of Participants Satisfied With Current Dressings — 3; 3; 5; 5 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Satisfied With Current Dressings	3; 3; 5; 5	—
PRIMARY Number of Participants Satisfied With Experimental Dressings	9; 8; 6; 1; 2; 3	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03142750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.