Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

N/ACompletedNCT01957384

Coloplast A/S25 enrolled

Overview

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma

Interventions

Coloplast Test product 1DEVICE

Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.

Coloplast Test product 2DEVICE

Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S

Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)DEVICE

Standard Care was the subject usual ostomy appliance and had to be one of the following: * Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, * Dansac: Nova 1 \& Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate * Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate * ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate * B. Braun: Flexima Active \& Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have given written informed consent * Be at least 18 years of age and have full legal capacity * Be able to handle the bags themselves or with help from caregiver * Have an ileostomy with a diameter between 15 and 45 mm * Have had their ostomy for at least three months * Currently use a 1-piece flat standard care product with open bag * Negative result of a pregnancy test for women of childbearing age * Custom-cut product user * Be suitable for participation in the investigation Exclusion Criteria: * Use irrigation during the study (flush the stoma with water) * Currently receiving or have within the past 2 months received radio- and/or chemotherapy * Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area * Are pregnant or breastfeeding * Participating in other interventional clinical investigations or have previously participated in this investigation * Max three days wear time * Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Locations (1)

Coloplast A/S

Humlebæk, Denmark

Outcomes

Primary Outcomes

Degree of Leakage

The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S

Time frame: Up to 14 days per test product

Data from ClinicalTrials.gov

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