What is the mechanism of action of this treatment?

Common treatments for feeding tube complications, such as abdominal wall leakage, include the use of stoma site accessories, proper tube placement techniques, and the application of barrier creams or dressings. Stoma site accessories, like the one studied in the trial, are designed to create a better seal around the feeding tube, preventing leakage by providing a snug fit and reducing movement. Proper tube placement ensures that the tube is correctly positioned to minimize irritation and leakage. Barrier creams and dressings protect the skin around the stoma from moisture and irritation, promoting healing and preventing infection. These treatments are crucial for patients as they help maintain the integrity of the stoma site, reduce the risk of infection, and improve overall comfort and quality of life.

What side effects are associated with this type of intervention?

Common treatments for feeding tube complications, such as the use of stoma site accessories to prevent abdominal wall leakage, can have side effects including local infection, irritation, and discomfort at the stoma site. In some cases, there may be an increased risk of granulation tissue formation, which can cause further irritation and require additional medical intervention. Additionally, improper placement or use of these accessories can lead to leakage or blockage of the feeding tube, necessitating further adjustments or replacements.

What prior FDA approvals exist?

The FDA has approved various devices and accessories for managing complications associated with feeding tubes, including those designed to prevent abdominal wall leakage. These devices often include specialized stoma site accessories and gastrostomy or jejunostomy tube components that ensure a secure fit and minimize leakage. While specific drug approvals for this purpose are limited, the focus has been on mechanical solutions developed by institutions like the Cleveland Clinic, which are used in clinical settings to enhance the safety and efficacy of long-term enteral feeding.

What other types of research exist?

Promising alternatives to the Stoma Site Accessory for preventing abdominal wall leakage in feeding tube patients include: 1) Advanced negative pressure wound therapy (NPWT) devices, which help manage exudate and promote healing; 2) Coated self-expanding stents, which can provide structural support and reduce leakage; 3) Novel biologic or synthetic mesh materials designed for enhanced integration and reduced infection risk; 4) Endoscopic vacuum therapy, which offers a minimally invasive option for managing leaks and promoting tissue healing.

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Enteral Feeding Tube Accessory

Accessory for Feeding Tube Complications (SSA Trial)

N/A

Waitlist Available

Led By Eric Yudelevich, MD

Research Sponsored by Eric Yudelevich

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6 visit

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new device for feeding tubes aimed at preventing leaks in patients with long-term feeding tubes. The device attaches to the tube and reduces leaks and friction at the insertion site, potentially improving comfort and reducing infection risk.

Who is the study for?

This trial is for adults aged 22 to 85 who have had a gastrostomy or jejunostomy feeding tube for at least 3 months and are scheduled for a tube replacement. Participants must understand the study, consent in writing, be able to take their temperature as required, and commit to follow-up procedures. Excluded are those needing sedation for tube changes, non-English speakers, pregnant women, people allergic to silicone, steroid or immunosuppressant users, recent participants in other trials, those unable to self-report or perform self-care.

What is being tested?

The trial tests a new stoma site accessory designed by Cleveland Clinic intended to prevent leakage around long-term feeding tubes. It's being compared with standard care during routine feeding tube replacements. The accessory is similar to FDA-approved components used with gastrostomy and jejunostomy tubes.

What are the potential side effects?

Potential side effects may include skin irritation or allergic reactions at the stoma site due to contact with the accessory material (medical-grade silicone), infection risks associated with any procedure involving enteral feeding tubes, and discomfort related to the placement of the new device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6 visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6 visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of feeding tube complications for each patient with a study accessory

Successful Accessory placement

Secondary study objectives

Characteristics of Pain and Leakage

Characteristics of Pain and Leakage Questionnaire

Quality of Life PROMIS 10 questionnaire

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stoma Site AccessoryExperimental Treatment1 Intervention

Stoma site accessory with enteral tube replacement procedure.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for feeding tube complications, such as abdominal wall leakage, include the use of stoma site accessories, proper tube placement techniques, and the application of barrier creams or dressings. Stoma site accessories, like the one studied in the trial, are designed to create a better seal around the feeding tube, preventing leakage by providing a snug fit and reducing movement. Proper tube placement ensures that the tube is correctly positioned to minimize irritation and leakage. Barrier creams and dressings protect the skin around the stoma from moisture and irritation, promoting healing and preventing infection. These treatments are crucial for patients as they help maintain the integrity of the stoma site, reduce the risk of infection, and improve overall comfort and quality of life.

Percutaneous endoscopic gastrostomy tube feeding in patients with head and neck cancer.