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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02362360
• Date of registration: 09/02/2015
• Prospective Registration: No
• Primary sponsor: Coloplast A/S
• Public title: Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
• Scientific title: Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
• Date of first enrolment: February 2015
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02362360
• Study type: Interventional
• Phase: N/A

Countries of recruitment

Denmark, Germany, Netherlands, Norway

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colostomy

Ileostomy

Intervention(s)

Device: Comparator (Hollister)

Device: Coloplast Test Product

Primary Outcome(s)

Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good". [Time Frame: 21 +/- 3 days]

Secondary ID(s)

CP255

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/10/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02362360