Actively Recruiting

Phase Not Applicable
Age: 7Years - 21Years
All Genders
NCT07115134

Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Led by Children's National Research Institute · Updated on 2025-08-11

75

Participants Needed

1

Research Sites

168 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. This study compares several outcomes related to complications from gastrostomy tube placement using a prospective cohort of patients and a retrospective analysis of complications associated with gastrostomy tubes. Prospective patients will initially be monitored until they have completed their last dressing change or for a maximum of 50 days. They will then complete their final survey. Their charts will be reviewed for up to one year from their initial gastrostomy placement. The study's primary objective is to determine if the novel gastrostomy tube anchor dressing reduces rates of gastrostomy tube dislodgement and ED/clinic visits for gastrostomy tube complications.

CONDITIONS

Official Title

Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Who Can Participate

Age: 7Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.
Not Eligible

You will not qualify if you...

  • Patients with a skin condition that limits the placement of the dressing, as confirmed by the clinical team.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's National Hospital

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

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Research Team

A

Anthony Sandler

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing | DecenTrialz