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Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

NCT07115134 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-08-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2027-12-18
Completion
2027-12-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115134 on ClinicalTrials.gov