Ileostomy
Conditions
Brief summary
Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices. The secondary objective is to investigate several performance and safety parameters of the various devices. The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed. Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development. The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users. Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.
Interventions
DEVICEOstomy appliance: convex 1-piece drainable
8 variations of an ostomy devices are tested
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years old * Have signed the declaration of informed consent * Have an ileostomy in a concave area * Have had an ileostomy for at least three months * Have used convex plates (for convex users) or flat plates (for flat plate users) for the last month * Be users of 1-piece or 2-piece open ostomy devices * Have an ileostomy with a diameter of less than 33 mm
Exclusion criteria
* Are pregnant or breast-feeding * Have a double-loop ileostomy * Have known hypersensitivity or allergy to the devices' component ingredients * Are receiving/have received radiation treatment and/or chemotherapy within the last 3 months. * Are receiving/have received local peristomal or systemic steroid treatment within the last month * 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 | One week | The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate. The scale was developed by Coloplast A/S |
Countries
Denmark
Participant flow
Recruitment details
The subject were recruited through the Coloplast A/S user database in Denmark.
Pre-assignment details
The investigation consisted of two periods: in the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts, Test A\*-D\*, were developed and tested. The test products were not randomised. The test order in first round was Test A - Test D and in second round it was Test A\*-Test D\*.
Participants by arm
| Arm | Count |
|---|---|
| Convex Product Users Subjects who usually use a convex product | 23 |
| Flat Product Users Subjects who usually use a flat product | 9 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Test Period 1; Test A | Break from study holiday | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Test Period 1; Test A | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Test Period 1; Test B | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Test Period 1; Test D | Subject took a break due to holiday | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Test Period 2; Test A* | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Test Period 2; Test A* | Holiday | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Test Period 2; Test B* | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Test Period 2; Test C* | holiday | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Test Period 2; Test C* | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Test Period 2; Test C* | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Convex Product Users | Flat Product Users | Total |
|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 11.9 | 64.4 years STANDARD_DEVIATION 7.5 | 60.8 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 18 Participants | 5 Participants | 23 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 26 | 6 / 24 | 4 / 24 | 3 / 26 | 3 / 28 | 3 / 28 | 1 / 26 | 3 / 23 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 | 0 / 24 | 0 / 26 | 1 / 28 | 0 / 28 | 0 / 26 | 0 / 23 |
Outcome results
Primary
Degree of Leakage
The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate. The scale was developed by Coloplast A/S
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test A - Convex Product Users | Degree of Leakage | 4.2 units on a scale | Standard Deviation 0.6 |
| Test B - Convex Product Users | Degree of Leakage | 4.3 units on a scale | Standard Deviation 0.8 |
| Test C - Convex Product Users | Degree of Leakage | 4.4 units on a scale | Standard Deviation 0.7 |
| Test D - Convex Product Users | Degree of Leakage | 4.3 units on a scale | Standard Deviation 0.8 |
| Test A* - Convex Product Users | Degree of Leakage | 3.4 units on a scale | Standard Deviation 0.7 |
| Test B* - Convex Product Users | Degree of Leakage | 2.9 units on a scale | Standard Deviation 0.6 |
| Test C* - Convex Product Users | Degree of Leakage | 3.3 units on a scale | Standard Deviation 0.7 |
| Test D* - Convex Product Users | Degree of Leakage | 4.1 units on a scale | Standard Deviation 0.8 |
| Test A - Flat Product Users | Degree of Leakage | 2.1 units on a scale | Standard Deviation 1.4 |
| Test B - Flat Product Users | Degree of Leakage | 0.1 units on a scale | Standard Deviation 0.04 |
| Test C - Flat Product Users | Degree of Leakage | 0.1 units on a scale | Standard Deviation 0.1 |
| Test D - Flat Product Users | Degree of Leakage | 2.4 units on a scale | Standard Deviation 1.3 |
| Test A* - Flat Product Users | Degree of Leakage | 3.1 units on a scale | Standard Deviation 1.5 |
| Test B* - Flat Product Users | Degree of Leakage | 3.6 units on a scale | Standard Deviation 1.8 |
| Test C* - Flat Product Users | Degree of Leakage | 3.8 units on a scale | Standard Deviation 1.8 |
| Test D* - Flat Product Users | Degree of Leakage | 3.0 units on a scale | Standard Deviation 1.6 |