Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bearables Gastrostomy Tube Dressing.
- Who it may be relevant to
- Registry conditions: Gastroenterology Surgery, Tube Feeding. Basic parameters: 7 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 structu
Primary outcome measures
- Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement [Time frame: Up to one year]
- Gastrostomy tube complications [Time frame: Up to one year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Children's National Hospital — Washington D.C.
Identifiers
NCT: NCT07115134 · STUDY00001158