Ileostomy - Stoma
Conditions
Brief summary
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
Detailed description
The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products
Interventions
DEVICEColoplast SenSura
SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.
DEVICEColoplast Test Product 1
Coloplast Test product 1 is a newly developed 1-piece ostomy appliance
DEVICEColoplast Test Product 2
Coloplast Test product 2 is a newly developed 1-piece 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
1. Have given written informed consent and signed letter of authority (mandatory in DK) 2. Be at least 18 years of age and have full legal capacity. 3. Be able to handle the products themselves 4. Have an ileostomy with a diameter between 10 and 40 mm. 5. Have had their ostomy for at least three months. 6. Have within the last month used a 1-piece flat product with open bag 7. Currently using midi or maxi bags 8. Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time. 9. Be suitable for participation in the investigation 10. Must be able to use custom cut product 11. Negative result of a pregnancy test for women of childbearing age (only DK)
Exclusion criteria
1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy. 2. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area 3. Are pregnant or breastfeeding 4. Participating in other interventional clinical investigations or have previously participated in this investigation 5. Has participated in the previous explorative Coloplast studies CP236 and CP237 6. Are currently or during the study using ostomy belt 7. Has a stoma below skin surface 8. Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin) 9. Has known hypersensitivity towards any of the test products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage | 14 +- 1 days | The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change. |
Countries
Denmark, Netherlands, Norway, United Kingdom
Participant flow
Recruitment details
The subjects were recruited through the Coloplast database and hospital sites.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects | 174 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Test Period 1 (2 Weeks) | Adverse Event | 0 | 1 | 1 | 0 | 1 | 0 |
| Test Period 1 (2 Weeks) | Lost to Follow-up | 2 | 0 | 1 | 1 | 0 | 0 |
| Test Period 1 (2 Weeks) | Protocol Violation | 1 | 2 | 2 | 1 | 0 | 3 |
| Test Period 1 (2 Weeks) | screen failure | 0 | 0 | 0 | 0 | 0 | 1 |
| Test Period 1 (2 Weeks) | subject did not want to wait for cut bag | 0 | 0 | 0 | 0 | 1 | 0 |
| Test Period 1 (2 Weeks) | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 2 |
| Test Period 2 (2 Weeks) | Adverse Event | 0 | 0 | 0 | 0 | 2 | 0 |
| Test Period 2 (2 Weeks) | Discontinue due to personal problems | 0 | 0 | 0 | 0 | 0 | 1 |
| Test Period 2 (2 Weeks) | Other | 1 | 0 | 0 | 0 | 0 | 0 |
| Test Period 2 (2 Weeks) | Protocol Violation | 2 | 0 | 1 | 1 | 0 | 0 |
| Test Period 2 (2 Weeks) | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 |
| Test Period 3 (2 Weeks) | Lack of Efficacy | 0 | 1 | 0 | 0 | 0 | 0 |
| Test Period 3 (2 Weeks) | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 103 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 | 38 / 162 | 24 / 163 | 27 / 163 |
| serious Total, serious adverse events | 3 / 162 | 2 / 163 | 5 / 163 |
Outcome results
Primary
Leakage
The fraction 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 +- 1 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test 1 | Leakage | 50 percentage of baseplates |
| Test 2 | Leakage | 61 percentage of baseplates |
| SenSura | Leakage | 59 percentage of baseplates |