An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

Ileostomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351817
• Other study ID #: CP256
• Status: Completed
• Phase: N/A
• First received: January 27, 2015
• Last updated: December 7, 2015
• Start date: February 2015
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have given written informed consent and letter of authority

• Be at least 18 years of age and have full legal capacity

• Be able to handle the products her/himself

• Have an ileostomy with a diameter between 10 and 30 mm

• Willing to follow the product change schedule (one change per day)

• Have had their ostomy for at least three months

• Willing to use 1 piece open ostomy products during the test period

• Must be able to use a custom cut product

• Have intact skin

• Negative result of a pregnancy test for women of childbearing age

Exclusion Criteria:

• Currently receiving or have within the past 2 months received radio- and/or chemotherapy

• Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment

• Is pregnant or breastfeeding.

• Is participating in other interventional clinical investigations or have previously participated in this investigation

• Have a loop ileostomy

• Known hypersensitivity towards any of the test products

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ileostomy

Intervention

Device:
• Test A
Ostomy appliance
• Test B
Ostomy appliance
• Baseline
Ostomy appliance

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebaek

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product Acceptance	Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products.; There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate.; The result presented below shows how many subjects preferred Test A/Test B over own product	7 days per test period	No