Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 21
Healthy Volunteers: f
View:

• Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.

Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Anthony Sandler
asandler@childrensnational.org
202-476-5760
Time Frame
Start Date: 2024-09-24
Estimated Completion Date: 2027-12-18
Participants
Target number of participants: 75
Treatments
Experimental: Bearables Gastrostomy Tube Dressing Prototype
Related Therapeutic Areas
Sponsors
Leads: Children's National Research Institute

This content was sourced from clinicaltrials.gov