Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management

Not Applicable

Terminated

• Conditions: Stoma Site Leakage
• Interventions: Device: OstoRing®

• Registration Number: NCT04802538
• Lead Sponsor: NorthShore University HealthSystem

Brief Summary

In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.

Detailed Description

In this crossover design trial, patients will be asked to first wear their normal ostomy pouching equipment for 28 days followed by 28 days with the OstoRing®. Patients may choose to continue using the OstoRing for an additional 19 days. Study visits will occur between each section of the trial and will involve a skin assessment and quality of life questionnaires. Additionally, over the course of the trial, participants will be asked to fill out a survey and take a picture of their stoma with ostomy pouching change.

Study Timeline

• Study Start: 2020-11-06
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Primary Completion: 2021-08-04
• Study Completion: 2021-08-04
• Status Verified: 2022-03
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Are at least 18 years of age and have full legal capacity
• Have had an end or loop ileostomy or colostomy for at least 6 months.
• Have used a Hollister 2 piece New Image pouching system for at least 8 weeks
• Able to provide informed consent
• Have a stoma with a diameter of 57mm or less
• Change their pouching system at least two times in seven days

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Exclusion Criteria

• Unable to give informed consent.
• Are pregnant or currently breastfeeding.
• In the last 2 months has received or is currently receiving, chemotherapy or radiation therapy.
• In the last month has received or is currently receiving systemic or local steroid treatment in the peristomal area.
• Currently suffering from severe peristomal skin problems such as peristomal pyoderma, abscess.
• Currently suffering from a peristomal hernia.
• Known hypersensitivity toward any of the test product (OstoRing® is made of surgical grade stainless steel)
• In the last 30 days has participated or is currently participating in a clinical study
• Assessed with an ostomy skin tool score of ≥3

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	OstoRing®	All patients will begin the study by using their normal ostomy pouching equipment for 28 days. This will be followed by a transition to using the OstoRing® for 28-47 days.

Primary Outcome Measures

Name	Time	Method
Pouching Equipment Wear Time/Lifespan	75 days	Mean pouching system wear time will be calculated with and without the OstoRing®.
Coloplast Tool Skin Assessment Score	75 days	The skin surrounding the peristomal area will be assessed at all study visits utilizing the coloplast skin score tool. Skin score may range from 0 to 15 with a smaller score indicating better skin condition in the peristomal area.

Secondary Outcome Measures

Name	Time	Method
City of Hope Quality of Life Ostomy Questionnaire Score	75 days	Quality of life will be assessed at all study visits utilizing the City of Hope Quality of Life Ostomy Questionnaire. This instrument contains 43 questions with answers on a Likert scale from 1 to 10. The final score is the sum of all responses divided by the total number questions which gives a final score from 1 to 10. Greater score on this survey is indicative of a better quality of life.

Trial Locations

Locations (1)

NorthShore University HealthSystem Evanston Hospital; 🇺🇸 Evanston, Illinois, United States