Ileostomy - Stoma
Conditions
Brief summary
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
Interventions
DEVICEColoplast Test product 1
Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.
DEVICEColoplast Test product 2
Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S
DEVICEStandard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
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
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Leakage | Up to 14 days per test product | 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 |
Countries
Denmark
Participant flow
Recruitment details
The subjects were recruited through the Coloplast database in Denmark
Pre-assignment details
25 subjects signed informed consent and were randomized. 2 subjects were screening failures and did not test any products. One subject violated an inclusion criterion (convex user). The subject tested both test products and is therefore included in the safety population. The 3 subjects are not included in the participant flow below.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 28.4 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 22 | 6 / 22 | 3 / 22 |
| serious Total, serious adverse events | 1 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coloplast Test Product 1 | Degree of Leakage | 4 units on a scale | Standard Deviation 5 |
| Coloplast Test Product 2 | Degree of Leakage | 4.6 units on a scale | Standard Deviation 5.6 |
| Standard Care | Degree of Leakage | 2.6 units on a scale | Standard Deviation 3.7 |