An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

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

Study Overview

• Status: Completed
• Conditions: Ileostomy
• Intervention / Treatment: Device: Test A; Device: Test B; Device: Baseline

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebaek, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baseline - Test A - Test B; Three period investigation. First each subject tests baseline product, then Test A and finally Test B. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces	Device: Test A; Ostomy appliance; Device: Test B; Ostomy appliance; Device: Baseline; Ostomy appliance
Experimental: Baseline - Test B - Test A; First each subject tests baseline product, then Test B and finally Test A. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces	Device: Test A; Ostomy appliance; Device: Test B; Ostomy appliance; Device: Baseline; Ostomy appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Birte Petersen Jakobsen, MD, Coloplast A/S

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Estimate): January 6, 2016
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CP256