Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy

Study Overview
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Brief Summary
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Introduction: It is not an illness to have an ostomy, even though it is an indication of previous serious illness, such as cancer, which is the reason for approximately 80% of all ostomy operations. Ostomies can be divided into three categories: colostomy (large intestine), ileostomy (small intestine) and urostomy (urinary tract). All require surgical redirection of the intestine or urinary tract, allowing for elimination of urine and faeces by means of an opening in the abdominal wall. For the population included in this study, subject with an ileostomy, colitis ulcerosa is the main cause for an ileostomy where a surgical removal of the colon and rectum resulting in an ileostomy in theory cures the disease. It can be very challenging to live with an ostomy and modern ostomy products should make life as easy as possible for people with ostomies. Leakage and peristomal skin problems have been found to have a negative effect on the quality of life for people with ostomies. The skin problems are the reason for one out of three visits to ostomy nurses and occur much more frequently in people who have had ileostomies than in those who have had colostomies. It has been observed that the prevalence of peristomal skin problems is 21-60% among people who have ileostomies, 13-35% among those who have colostomies and 21-48% among those who have urostomies. Leakage from ostomies that comes into contact with the skin is thought to predispose the patient to peristomal skin problems. One investigation of peristomal skin problems found that 77% of cases were related to contact with faeces or urine. There are several reasons why leakage from an ostomy occurs, such as uneven peristomal area, improper handling of the ostomy product or a problematic ostomy (its formation, its location, retraction, prolapse or hernia). The ostomy may also change size with time, which can lead to leakage, if the ostomy products are not adapted accordingly. As a general rule, a check-up of the ostomy by an ostomy nurse or a doctor together with educational support can reduce these problems. Modern ostomy products should, however, also be constantly developed in order to lessen to the greatest extent possible the risk of leakage and associated inconveniences.

Detailed Description
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See brief summary

Official Title
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An Open-labelled, Randomised, Controlled, Comparative, Explorative, Cross-over Study Investigating Safety and Performance of a New 1-piece Ostomy Product Compared Standard Care Ostomy Products in Subjects With Ileostomy

Conditions
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Leakage, Skin Condition

Intervention / Treatment
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* Device: Standard Care
* Device: River


Participation Criteria
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Eligibility Criteria
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List of Inclusion Criteria: Have given written informed consent. Are at least 18 years old. Have mental capacity to understand the study guidelines and questionnaires. Have had their ileostomy for at least 3 months Have an ileostomy with a diameter be-tween 19-40 mm. Are currently using a flat 1-piece product. Are able to change the product by them-selves or with help from a caregiver (e.g. spouse) Have experienced leakage under the base plate at least once a week over the last 2 weeks. List of Exclusion criteria. Pregnant or breast-feeding. Currently receiving or have within the past 2 months received radio- and/or chemotherapy. Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted). Are currently using a convex product Participating in other clinical studies or have previously participated in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: River<br> | Device: River<br>* River is a new developed product with Coloplast as manufacturer<br>|
| Active Comparator: Standard Care<br>Standard Care can have several manufacture and brand names. Standard Care is defined af the participants currently used stoma care product. | Device: Standard Care<br>* Participants are using their own product and this procedure is called Standard Care. Standard Care are the participants own products and may consist of several manufacturer and brand names.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage underneath the baseplate |  | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peristomal skin condition | Measured by the Ostomy Skin Tool | Two weeks | 
| Security | The participants feeling of security when wearing the product, measured on a 5-point scale | Two weeks | 
| Handling | The participants ease of handling the products, measured on a 5-point scale | Two weeks | 
| Comfort | The participants feeling of comfort when wearing the product, measured on a 5-point scale | Two weeks | 
| Adverse events |  | Two weeks |