Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

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.

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Key information

Conditions

Gastroenterology Surgery Tube Feeding

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital

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

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bearables Gastrostomy Tube Dressing

Device

The gastrostomy tube dressing in its current design is composed of two parts, both of which are external to the patient: one part is rigid and holds the gastrostomy at a fixed position, this is a 3D printed design that is produced here. The second part is a 3" x 3" flexible, cushioned, biocompatible adhesive bandage designed to fit around the skin opening (Silicone Foam Dressing, NH NeuHeils, USA). The design is subject to minor changes including the number of parts and location with the structure of the padding and securement but will continue to be designed with comfort as a priority. After assembly, the device is packaged (sterilization pouches, Plastcareusa, USA), sealed, and sanitized using UV light prior to patient use.

Primary outcomes

Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement

Time frame: Up to one year

Current rates of gastrostomy tube complications and dislodgement will be evaluated with our retrospective review, then compared to rates of complications and dislodgement after our novel dressing placement. This was chosen as complications after gastrostomy tube placement are high, and we believe that our dressing will lower them.
Gastrostomy tube complications

Time frame: Up to one year

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Sandler

CONTACT

[email protected]

202-476-5760

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Acronym: Tube Anchor

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Aug 11, 2025
Registry last updated: Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed