Prototype anchor dressing for button gastrostomy tubes
Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
NA · Children's National Research Institute · NCT07115134
This study will test whether a new adhesive anchor dressing reduces accidental removal and clinic/ER visits for patients getting button gastrostomy tubes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 7 Years to 21 Years |
| Sex | All |
| Sponsor | Children's National Research Institute (other) |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT07115134 on ClinicalTrials.gov |
What this trial studies
This is a single-center prospective cohort study with a retrospective comparator arm, testing a prototype gastrostomy tube anchor dressing (Bearables) for use with button gastrostomy tubes. The dressing has already undergone usability testing with parents, patients, and nurses, and this study tracks clinical outcomes including tube dislodgement and healthcare visits for tube complications. Prospective participants are followed through their last dressing change or up to 50 days, complete a final survey, and have their charts reviewed for up to one year after tube placement. The primary goal is to see if the anchor dressing lowers rates of dislodgement and ED/clinic visits compared with historical complication rates.
Who should consider this trial
Good fit: Patients undergoing button gastrostomy tube placement or within five days after placement who can have the prototype dressing applied and do not have skin conditions preventing placement are ideal candidates.
Not a fit: Patients with skin conditions that prevent dressing placement, non-button gastrostomy tubes, or clinical situations that inherently cause frequent dislodgement may not benefit from this dressing.
Why it matters
Potential benefit: If successful, the dressing could lower the chance of tube dislodgement and reduce emergency and clinic visits, easing care for patients and caregivers.
How similar studies have performed: Other anchor dressings have limited clinical outcome data and this specific prototype has only completed usability testing to date, so its efficacy for reducing dislodgement is unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- Children's National Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
Study contacts
- Study coordinator: Anthony Sandler
- Email: asandler@childrensnational.org
- Phone: 202-476-5760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastroenterology Surgery, Tube Feeding