NCT07115134

Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 7 Years – 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-09-24
• Primary completion: 2027-12-18
• Completion: 2027-12-18
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study