Ileostomy - Stoma
Conditions
Brief summary
To investigate the performance and safety of the three 2-piece convex ostomy appliances
Interventions
DEVICEColoplast Test 1
Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
DEVICEColoplast Test 2
Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
DEVICEColoplast Test 3
Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects interested in participating in the clinical investigation must comply with the following criteria: 1. Are at least 18 years of age and have full legal capacity 2. Have had an ileostomy for at least 3 months. 3. Have used a convex ostomy appliance for the last month 4. Have given written informed consent 5. Have an ileostomy with a diameter of 33mm or less 6. Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks
Exclusion criteria
Subjects complying with the following criteria must be excluded from participation in the clinical investigation: 1. Have a loop ostomy (also called double-barrel or ostomy with two outlets) 2. Are pregnant\* or breastfeeding. 3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy. 4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area. 5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)). 6. Known hypersensitivity toward any of the test products \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Leakage | 14 days | The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate) |
Countries
Denmark
Participant flow
Recruitment details
Subjects are recruited from the Coloplast A/S user database in Denmark.
Pre-assignment details
The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised between Coloplast Test1 and Coloplast Test 2 In the third test period all subject test Coloplast Test 3
Participants by arm
| Arm | Count |
|---|---|
| Overall Population | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Test Period 1 | sudden leakage/small bag | 1 | 1 |
| Test Period 1 | Withdrawal by Subject | 1 | 0 |
| Test Period 2 | Adverse Event | 0 | 1 |
| Test Period 3 | Adverse Event | 1 | 2 |
| Test Period 3 | the adhesive did not work | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Population |
|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 25 | 15 / 24 | 12 / 22 | 3 / 26 |
| serious Total, serious adverse events | 0 / 25 | 1 / 24 | 0 / 22 | 1 / 26 |
Outcome results
Primary
Degree of Leakage
The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coloplast Test 1 | Degree of Leakage | 4.5 units on a scale | Standard Deviation 4.9 |
| Coloplast Test 2 | Degree of Leakage | 5.2 units on a scale | Standard Deviation 4.8 |
| Coloplast Test 3 | Degree of Leakage | 6.4 units on a scale | Standard Deviation 5.5 |
| Baseline - Own Product | Degree of Leakage | 6.8 units on a scale | Standard Deviation 6 |