Prototype anchor dressing for button gastrostomy tubes
Official title: Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
Run by Children's National Research Institute · NCT07115134 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 7 Years to 21 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | September 24, 2024 |
| Main results expected | December 18, 2027 |
| Study ends | December 18, 2027 |
| Registry record updated | August 11, 2025 |
| Trial ID | NCT07115134 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.