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

Not Applicable

Completed

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

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
First SenSura, Then Test product	SenSura	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.
First Test product; then SenSura	SenSura	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.
First Test product; then SenSura	Test product	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.
First SenSura, Then Test product	Test product	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.

Primary Outcome Measures

Name	Time	Method
Leakage (Percentage of All Baseplates With Leakage)	After each baseplate change over a period, of 7 days	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: 1. No leakage 2. Starting to leak (leakage under the baseplate) 3. Leakage (seepage of faeces resulting in leakage on clothes) 4. Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)