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

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Device: Test product; Device: SenSura

Study type: Interventional

Funder types: Industry

Identifiers

NCT01799239

CP237

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the bags themselves
4. Have an ileostomy with a diameter between 15 and 55 mm
5. Have had their ileostomy for at least 3 months
6. Currently use a 1-piece flat ostomy appliance with open bag
7. Use minimum 1 product every second day, i.e. maximum 2 days wear time
8. Be suitable for participation in the study and for using a standard adhesive, flat base plate
9. Must be able and willing to use custom cut products
10. Accept to test two 1-piece products within the study period

Exclusion criteria

1. Use irrigation during the study period (flush the intestines with water)
2. Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
3. Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area
4. Are pregnant or breastfeeding
5. Participating in other interventional clinical investigations or have previously participated in this investigation
6. Currently using a ostomy belt
7. Currently using extended wear product
8. Have a loop ileostomy
9. Known hypersensitivity towards any of the test products
10. Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

First Test product; then SenSura

Experimental group

Description:

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.

Treatment:

Device: Test product

Device: SenSura

First SenSura, Then Test product

Active Comparator group

Description:

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.

Treatment:

Device: Test product

Device: SenSura