Ileostomy - Stoma
Conditions
Brief summary
To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.
Interventions
DEVICEColoplast Test A
Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
DEVICEColoplast Test B
Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
DEVICEOwn product
Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
DEVICEColoplast Test C
Coloplast Test C is a new ostomy appliance developed by Coloplast A/S
DEVICEColoplast Test D
Coloplast Test D is a new ostomy appliance developed by Coloplast A/S
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. Had given written informed consent 2. Was at least 18 years of age 3. Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse) 4. Had an ileostomy with a diameter between 15-45 mm 5. Have had an ileostomy for at least 3 months 6. Currently used a 2-piece flat appliance
Exclusion criteria
1. Used irrigation during the investigation (flush stoma with water) 2. Currently received or had within the past 2 months received radio- and/or chemotherapy. 3. Currently received or had within the past month received local or systemic steroid treatment in the peristomal area. 4. Was pregnant or breast feeding 5. Participated in other interventional studies that could interfere with this one or had previously participated in this investigation. 6. Had a baseplate wear time of more than three days 7. Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Leakage | 14 days | Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome). |
Participant flow
Recruitment details
The subject were recruited through the Danish Coloplast user data base.
Pre-assignment details
28 subjects were randomized. However 2 subject were wrongly randomized. 1 subject was allocated to test Test D in the First period,1 subject First tested Test A followed by Test D. Two subject discontinued the testing of the new test products collected data on own product. These factors disturb the participant flow chart.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| First Test Period (Test A or Test C) | Adverse Event | 1 | 0 | 1 | 0 |
| First Test Period (Test A or Test C) | Lack of Efficacy | 5 | 3 | 0 | 0 |
| First Test Period (Test A or Test C) | Withdrawal by Subject | 1 | 1 | 0 | 0 |
| Second Test Period (Test B or Test D) | Lack of Efficacy | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 18 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 15 | 0 / 7 | 6 / 12 | 3 / 10 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 7 | 0 / 12 | 1 / 10 | 0 / 16 |
Outcome results
Primary
Degree of Leakage
Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coloplast Test A | Degree of Leakage | 6.4 units on a scale | Standard Deviation 5.5 |
| Coloplast Test B | Degree of Leakage | 3.4 units on a scale | Standard Deviation 4.2 |
| Coloplast Test C | Degree of Leakage | 7.0 units on a scale | Standard Deviation 4.7 |
| Coloplast Test D | Degree of Leakage | 7.0 units on a scale | Standard Deviation 4 |
| Own Product | Degree of Leakage | 1.9 units on a scale | Standard Deviation 3.1 |