Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Conditions

• Gastroenterology Surgery
• Tube Feeding

Eligibility Criteria

Sex

ALL

Age

7 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Sep 24, 2024

Status verified

Aug 2025

Primary completion

Dec 18, 2027

Completion

Dec 18, 2027

Study Design

Enrollment

75 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Bearables Gastrostomy Tube Dressing Prototype

Primary Outcome Measure

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

Central Contacts

• Anthony Sandler
  202-476-5760
  [email protected]

Locations (1)

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