An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

N/ACompletedNCT02351817

Coloplast A/S10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Ileostomy

Interventions

Test ADEVICE

Ostomy appliance

Test BDEVICE

Ostomy appliance

BaselineDEVICE

Ostomy appliance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Coloplast A/S

Humlebæk, Denmark

Outcomes

Primary Outcomes

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

Time frame: 7 days per test period

Data from ClinicalTrials.gov

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