Stoma - Ileostomy
Conditions
Brief summary
The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances
Interventions
DEVICEColoplast Test product Y
Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
DEVICEColoplast Test product Z
Coloplast Test product Z is a newly developed 2-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
1. Have given written informed consent and signed letter of authority. 2. Are at least 18 years of age and have full legal capacity. 3. Have had their ileostomy for at least 3 months. 4. Have used a 2-piece convex ostomy product during the last month. 5. Are willing and able to comply with investigation procedures. 6. Have an ileostomy with a diameter of 30 mm or less. 7. Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.
Exclusion criteria
1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin). 2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy. 3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment. 4. Are pregnant or breastfeeding. 5. Have a loop ostomy (also called double-barrel or ostomy with two outlets). 6. Known hypersensitivity toward any of the test products. 7. Participating in other interventional clinical investigations or have previously participated in this investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Leakage | 14 days | The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was measured at each baseplate change. |
Countries
Denmark
Participant flow
Recruitment details
The subjects were recruited through the danish Coloplast database.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Test Period 1 | Lack of Efficacy | 0 | 1 |
| Test Period 1 | Other | 1 | 0 |
| Test Period 1 | Withdrawal by Subject | 1 | 0 |
| Test Period 2 | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 18 | 8 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
Primary
Degree of Leakage
The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was measured at each baseplate change.
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Y | Degree of Leakage | 5.0 units on a scale | Standard Deviation 5.3 |
| Test Z | Degree of Leakage | 5.6 units on a scale | Standard Deviation 5.7 |