Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

Coloplast

Status: Completed

Conditions: Colostomy; Ileostomy

Treatments: Device: Coloplast Test Product; Device: Comparator (Hollister)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02362360

CP255

Details and patient eligibility

About

The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have given written informed consent and in DK: signed a letter of authority
• Be at least 18 years of age and have full legal capacity
• Have had their ileostomy or colostomy for at least 3 months
• Able to use a baseplate size 15 to 40 mm
• Be able to handle the product themselves
• Normally experience faeces under the baseplate at least 3 times during 2 weeks
• Currently using a 2-piece flat product with mechanical coupling
• Willing to test both the Coloplast test product and the comparator product
• Willing to use an open bag size maxi during the investigation
• Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)
• Willing to use at least 1 baseplate every 3rd day during the investigation
• Is able to use a custom cut product
• Be suitable for participating in the investigation

Exclusion criteria

• Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)
• Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed
• Are pregnant or breastfeeding
• Are participating in other interventional clinical investigations or have previously participated in this investigation
• Use irrigation during the investigation (flush the intestines with water)
• Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
• Have a loop ostomy
• Have known hypersensitivity towards any of the products used in the investigation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Coloplast Test Product then Comparator

Experimental group

Description:

The subject first tests the Coloplast Test Product and then tests the Comparator

Treatment:

Device: Coloplast Test Product

Device: Comparator (Hollister)

Comparator then Coloplast Test Product

Experimental group

Description:

The subject first tests the Comparator and then tests the Coloplast Test Product.

Treatment:

Device: Coloplast Test Product

Device: Comparator (Hollister)