Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Device: Coloplast test product; Device: SenSura

Study type: Interventional

Funder types: Industry

Identifiers

NCT01957553

CP243

Details and patient eligibility

About

The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product

Full description

The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.Have given written informed consent and letter of authority (DK only)
• 2.Be at least 18 years of age and have full legal capacity.
• 3.Be able to handle the products her/himself
• 4.Have an ileostomy with a diameter between 10 and 40 mm.
• 5.Have had their ostomy for at least three months.
• 6.Be willing to use minimum 2 base plates every week
• 7.Currently use 2-piece flat mechanical coupling product with open bag 8
• 11.Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion criteria

• 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
• 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• 3.Is pregnant or breastfeeding.
• 4.Is participating in other interventional clinical investigations or have previously participated in this investigation
• 5.Has participated in the previous explorative study CP234
• 7.Known hypersensitivity towards any of the test products
• 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

130 participants in 2 patient groups

Treatment sequence 1, First Coloplast Test product

Experimental group

Description:

Subjects first allocated to Coloplast Test product will after cross-over test SenSura

Treatment:

Device: SenSura

Device: Coloplast test product

Treatment seqence 2; First SenSura

Experimental group

Description:

Subjects first allocated to SenSura will after cross-over test Coloplast Test product

Treatment:

Device: SenSura

Device: Coloplast test product