Gastrostomy Tube Dressing for Tube Feeding

(Tube Anchor Trial)

Overseen By Anthony Sandler

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Skin condition

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of dressing, called Bearables Gastrostomy Tube Dressing, for individuals with gastrostomy tubes, which are used for feeding directly into the stomach. The goal is to determine if this dressing can reduce issues like the tube dislodging or requiring additional clinic visits. The trial suits those who have recently had a gastrostomy tube placed or are within five days of placement. Researchers will monitor participants for any issues up to 50 days after their last dressing change. As an unphased trial, this study allows participants to contribute to innovative research that could enhance care for future patients with gastrostomy tubes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the clinical team to get a clear answer.

What prior data suggests that this gastrostomy tube dressing is safe?

Research shows that the Bearables Gastrostomy Tube Dressing helps keep feeding tubes securely in place. These tubes deliver nutrition directly into the stomach. The dressing aims to prevent tube dislodgement and reduce unnecessary doctor visits.

Studies on feeding tube procedures and dressings indicate that while these methods are generally safe, problems can sometimes occur, such as minor skin irritation or discomfort around the tube site. However, with proper care and monitoring, these issues are often manageable. The Bearables dressing is part of ongoing efforts to improve the experience and reduce complications for individuals with feeding tubes.

As with any new medical product, monitoring for unexpected issues is crucial. Clinical trial participants will be closely observed for any signs of problems to ensure the product's safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional gauze and tape dressings used for gastrostomy tubes, the Bearables Gastrostomy Tube Dressing offers a unique design that specifically caters to the comfort and hygiene of patients. This innovative dressing is designed to reduce irritation and the risk of infection, which are common issues with standard dressings. Researchers are excited because it might provide a more comfortable and safer option for individuals who rely on tube feeding, improving their overall quality of life.

What evidence suggests that this gastrostomy tube dressing is effective for reducing complications?

Research has shown that using a gastrostomy tube, a tube inserted into the stomach for feeding, can improve nutrition and quality of life. In this trial, participants will use the Bearables Gastrostomy Tube Dressing, designed to keep these tubes secure. This dressing prevents the tube from coming loose, potentially reducing emergency room visits or other complications. Although specific studies on this dressing are limited, it aims to provide a more secure and comfortable experience for individuals with gastrostomy tubes, making tube feeding management easier and safer. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for patients who have had gastroenterology surgery, specifically those with button gastrostomy tubes for tube feeding. Participants should be willing to use the new Bearables Gastrostomy Tube Dressing and allow monitoring up to 50 days post-surgery, with chart reviews extending up to a year.

Inclusion Criteria

I am getting a feeding tube placed or had one placed within the last 5 days.

Exclusion Criteria

Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are monitored for up to 50 days during the use of the prototype gastrostomy tube anchor dressing

7 weeks

Regular visits for dressing changes

Follow-up

Participants' charts are reviewed for complications for up to one year from initial gastrostomy placement

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Bearables Gastrostomy Tube Dressing

Trial Overview The study tests a novel prototype of an anchor dressing designed for button gastrostomy tubes. It aims to see if this new dressing can reduce complications like tube dislodgement and emergency or clinic visits due to these issues by comparing current patient data with past records.

How Is the Trial Designed?

Group I: Bearables Gastrostomy Tube Dressing Prototype Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6566785/

The Effect of Enteral Tube Feeding on Patients' Health ... Enteral tube feeding has been shown to promote nutritional status, improve wound healing, and enhance patients' quality of life (QoL).

2. journals.lww.com journals.lww.com/jbisrir/fulltext/2009/07241/a_review_of_the_effectiveness_and_meaningfulness.11.aspx

JBI Evidence Synthesis Thirty three percent (n=271) of new patients registered (n=821) were gastrostomy fed, others were fed by nasogastric (66%, n=542) or jejunostomy tube (1%, n=8).

3. naspghan.org naspghan.org/files/documents/pdfs/training/curriculum-resources/nutrition/other%20guidelines_zeusdeleted_145_09102015010939/Bankhead_Enteral_practice_recommendations.pdf

Enteral Nutrition Practice Recommendations Special Report Randomised comparison of percutaneous endoscopic gastrostomy and nasogastric tube feeding in patients with persisting neurological dysphagia. BMJ. 1992;304 ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532876/

Enteral Feeding - StatPearls - NCBI Bookshelf Advantages of enteral nutrition over parenteral nutrition include safety, effectiveness, decreased risk of infection, decreased cost, prevention of gut atrophy, ...

5. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-020-02003-x

Long‐term prognosis of enteral feeding and parenteral ... Approximately 58% to 87% patients aged ≥75 years died within 730 days after initiation of nutrition through GS, NGT, or PN. Patients with non- ...

6. saxinstitute.org.au saxinstitute.org.au/wp-content/uploads/Gastrostomy-guidelines-a-rapid-review.pdf

Gastrostomy guidelines: a rapid review Randomised prospective study: assess the safety of early feeding after PEG placement. • 112 patients referred for PEG insertion were randomised to begin tube ...

7. publications.aap.org publications.aap.org/pediatricsinreview/article/45/4/175/196894/Gastrostomy-Tubes-Indications-Types-and-Care

Gastrostomy Tubes: Indications, Types, and Care Despite the overall safety of these procedures, both early and late complications can occur. It is important for pediatricians and pediatric ...

8. hytape.com hytape.com/latest-news/a-comprehensive-guide-to-securing-a-g-tube-best-practices-and-tips-from-medical-professionals/?srsltid=AfmBOoqIv7KN2Wb9USYlK1sgfJ_HGCYR_x9NST-pWh3tLOmP4s5CN5ff

A Comprehensive Guide to Securing a G-tube: Best ... To protect the G-tube during bathing, it is recommended to cover the site with a waterproof dressing or a specialized G-tube cover. These ...

9. mskcc.org mskcc.org/cancer-care/patient-education/caring-drainage-gastrostomy-tube

Caring for Your Drainage Gastrostomy Tube 1 Cath-Secure®. Polyderm™ dressing. Your healthcare provider may also prescribe pain medication to relieve discomfort you may have around your drainage g-tube.

10. childrenscolorado.org childrenscolorado.org/globalassets/community/school-nurse/gastroenterology/gastro_g-tubecarebooklet_eng.pdf

Care of a Gastrostomy Tube After the first 8 weeks you can leave the site open to air without a dressing. ... When not in use, remove the extension tube and close the G-tube safety cap.