Ileostomy - Stoma
Conditions
Brief summary
The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.
Interventions
DEVICEColoplast Test product
Coloplast test product is a newly developed 1-piece ostomy appliance
DEVICEStandard Care
Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Be able to handle the appliance themselves or with help from caregiver (e.g. spouse) 4. Have an ileostomy with a diameter between 15 and 45 mm 5. Have had their ostomy for at least three months 6. Currently use a 1-piece flat product with open bag 7. Use minimum 1 product every second day. 8. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate 9. Must use custom cut product 10. Accept to test two 1-piece products within the study
Exclusion criteria
1. Use irrigation during the study (flush the stoma with water) 2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy 3. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area 4. Are pregnant or breastfeeding 5. Participating in other interventional clinical investigations or have previously participated in this investigation 6. Has more than three days wear time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage | 14+/-3 days per product | The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change. |
Countries
Netherlands
Participant flow
Pre-assignment details
Not completed includes those who did not complete the entire period (those that did not try all products within the period) and then continued to next period, if relevant.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 4 | 0 |
| Period 1 | Lack of Efficacy | 1 | 0 |
| Period 1 | Trial stopped by sponsor | 1 | 3 |
| Period 1 | Withdrawal by Subject | 1 | 0 |
| Period 2 | Adverse Event | 0 | 1 |
| Period 2 | Lack of Efficacy | 0 | 2 |
| Period 2 | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment France | 6 participants |
| Region of Enrollment Netherlands | 17 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 20 | 6 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Leakage
The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Time frame: 14+/-3 days per product
Population: Intention-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coloplast Test Product | Leakage | 50 percentage of baseplates with no leakage |
| Standard Care | Leakage | 77 percentage of baseplates with no leakage |