Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Children's National

Status: Enrolling

Conditions: Gastroenterology Surgery; Tube Feeding

Treatments: Device: Bearables Gastrostomy Tube Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT07115134

STUDY00001158

Details and patient eligibility

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 7 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Bearables Gastrostomy Tube Dressing Prototype

Experimental group

Treatment:

Device: Bearables Gastrostomy Tube Dressing