Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

Study Overview
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Brief Summary
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The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

Official Title
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Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Device: Test product
* Device: SenSura


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Be able to handle the bags themselves Have an ileostomy with a diameter between 15 and 55 mm Have had their ileostomy for at least 3 months Currently use a 1-piece flat ostomy appliance with open bag Use minimum 1 product every second day, i.e. maximum 2 days wear time Be suitable for participation in the study and for using a standard adhesive, flat base plate Must be able and willing to use custom cut products Accept to test two 1-piece products within the study period Exclusion Criteria: Use irrigation during the study period (flush the intestines with water) Currently receiving or have within the past 2 months received chemotherapy or radiation therapy Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area Are pregnant or breastfeeding Participating in other interventional clinical investigations or have previously participated in this investigation Currently using a ostomy belt Currently using extended wear product Have a loop ileostomy Known hypersensitivity towards any of the test products Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Test product; then SenSura<br>The subject in this arm first test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. After cross-over the subject test SenSura which is CE-marked and commerical available. | Device: Test product<br>* The test product consists of an adhesive with a new top film<br>Device: SenSura<br>* SenSura is the CE-marked and commercially available comparator product<br>|
| Active Comparator: First SenSura, Then Test product<br>The subject in this arm first test SenSura which is CE-marked and commerical available. After cross-over the subject test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. | Device: Test product<br>* The test product consists of an adhesive with a new top film<br>Device: SenSura<br>* SenSura is the CE-marked and commercially available comparator product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage (Percentage of All Baseplates With Leakage) | leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers: No leakage Starting to leak (leakage under the baseplate) Leakage (seepage of faeces resulting in leakage on clothes) Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate) | After each baseplate change over a period, of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stoma ileostomy