Ileostomy - Stoma
Conditions
Brief summary
To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances
Interventions
DEVICEColoplast Test 1
Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance
DEVICEColoplast Test 2
Coloplast Test 2 is a newly developed 1-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 must comply with the following criteria in order to participate in the investigation: 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 33 mm or less 6. Have experience 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 (adreno-cortical hormone) in the peristomal area 5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)) 6. Are currently participating in another clinical investigation or has previously participated in this investigation
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 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate) |
Countries
Netherlands
Participant flow
Recruitment details
The subject were recruited through the Coloplast database in The Netherlands
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All the subjects in one group | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Test Period 1 | Adverse Event | 0 | 1 |
| Test Period 1 | Withdrawal by Subject | 0 | 1 |
| Test Period 2 | Adverse Event | 1 | 0 |
| Test Period 2 | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 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 | 3 / 16 | 1 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Degree of Leakage
The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coloplast Test 1 | Degree of Leakage | 1.9 units on a scale | Standard Deviation 4.2 |
| Coloplast Test 2 | Degree of Leakage | 2.5 units on a scale | Standard Deviation 4.3 |
| Basline - Own Product | Degree of Leakage | 3.1 units on a scale | Standard Deviation 5.7 |