CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Gastrostomy tube dressingdevice
Likely dose
Not stated in record
Key inclusion· 3
  • Pre-existing gastrostomy (G-tube)
  • Presenting to G-tube or surgery clinic for G-tube replacement
  • Admitted to hospital with pre-existing G-tube for unrelated reasons but with G-tube site issues
Key exclusion· 5
  • Uses gastrostomy tube type other than Mini Balloon Button
  • Parents or legal guardians cannot be reached by telephone
  • Prisoner status
  • Pregnant women

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03142750
NCT03142750N/ACompleted

Design of a Dressing for Gastrostomy Buttons in Pediatric Population

University of Colorado, Denver·interventional·Posted May 5, 2017·Updated Jan 18, 2020

In Brief

A clinical study evaluating Gastrostomy tube dressing for Gastrostomy Complications. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 5, 2017
Enrollment StartSep 1, 2017
Primary CompletionMay 15, 2018
Study CompletionAug 30, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.2 years ago

Interventions

Gastrostomy tube dressingdevice

Two types of dressings to secure gastrostomy tube in children