Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-21
SponsorChildren's National Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.
Disqualifiers
1. Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team
Trial design
Design model
Single group
Treatments tested in this trial
Bearables Gastrostomy Tube Dressing
DeviceThe 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.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Bearables Gastrostomy Tube Dressing PrototypeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement
Current rates of gastrostomy tube complications and dislodgement will be evaluated with our retrospective review, then compared to rates of complications and dislodgement after our novel dressing placement. This was chosen as complications after gastrostomy tube placement are high, and we believe that our dressing will lower them.
Time frame
Up to one year2
Gastrostomy tube complications
Time frame
Up to one yearSponsors and contacts
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Source ClinicalTrials.gov