N/A
N=24
Design of a Dressing for Gastrostomy Buttons in Pediatric Population
Gastrostomy Complications
Bottom Line
View on ClinicalTrials.gov: NCT03142750 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Number of Participants Satisfied With Current Dressings — 3; 3; 5; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gastrostomy tube dressing (Device)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2018
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 | — |
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.
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
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.