Recruiting

Gastrostomy Anchor Dressing

Sponsor:

Children's National Research Institute

Code:

NCT07115134

Conditions

Gastroenterology Surgery

Tube Feeding

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

Interventions

Bearables Gastrostomy Tube Dressing

Study Details

Brief summary:

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

Gastroenterology Surgery

Tube Feeding

Study ID

NCT07115134

Start date

Sep 24, 2024

Status verified date

Aug, 2025

Completion date

Dec 18, 2027

Anticipated

Primary completion date

Dec 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Bearables Gastrostomy Tube Dressing Prototype

Interventions

Bearables Gastrostomy Tube Dressing

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 outcome measure

  • Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement [ Time Frame: Up to one year ]
  • Gastrostomy tube complications [ Time Frame: Up to one year ]

Central Contacts and Locations

Central contacts

Anthony Sandler

202-476-5760asandler@childrensnational.org

Locations

Children's National Hospital

Recruiting

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

More Information

Sponsor

Children's National Research Institute

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2025-08-11.