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Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Who can join

Ages 7 to 21 · All sexes

Inclusion Criteria:

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

Exclusion Criteria:

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

About the study

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.

What is being tested

• Bearables Gastrostomy Tube Dressing (device)

Sponsor: Children's National Research Institute · Participants: 75 · Started: Sep 24, 2024

Contact the study team

• Anthony Sandler · Phone: 202-476-5760

Official record on ClinicalTrials.gov — NCT07115134

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.