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

Endeavor Health3 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Stoma Site Leakage

Interventions

OstoRing®DEVICE

Participants will use the OstoRing® along with their standard pouching equipment.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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

Locations (1)

NorthShore University HealthSystem Evanston Hospital

Evanston, Illinois, United States

Outcomes

Primary Outcomes

Pouching Equipment Wear Time/Lifespan

Mean pouching system wear time will be calculated with and without the OstoRing®.

Time frame: 75 days

Coloplast Tool Skin Assessment Score

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.

Time frame: 75 days

Secondary Outcomes

City of Hope Quality of Life Ostomy Questionnaire Score

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.

Time frame: 75 days

Data from ClinicalTrials.gov

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