Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Recruiting now · Not applicable

Conditions studied: Gastroenterology Surgery, Tube Feeding

In brief

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.

Key facts

Study ID

NCT07115134

Run by

Children's National Research Institute

People needed

75

Starts

2024-09-24

Expected to finish

2027-12-18

Last updated by the study team

2025-08-11

Who can join

Age: 7 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.

You may not qualify if…

• 1. Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team

Where it is running

• Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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