Stoma Site Leakage
Conditions
Keywords
ileostomy, colostomy, stoma
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.
Interventions
DEVICEOstoRing®
Participants will use the OstoRing® along with their standard pouching equipment.
Sponsors
Endeavor Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Early feasibility device study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed