Leakage, Skin Condition
Conditions
Brief summary
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates. The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates. The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates. Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods. The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period. 100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.
Interventions
DEVICENew ostomy base plate (SS)
The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
DEVICEStandard Care base plate
The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have given written Informed Consent 2. Is at least 18 years old 3. Has the mental capacity to understand the study guidelines and questionnaires 4. Has had their ileostomy for at least 3 months 5. Has an ileostomy with a diameter between 19-40 mm 6. Is currently using a flat 2-piece product with with mechanical coupling 7. Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse) 8. Has experienced leakage under the base plate at least once a week over the last 2 weeks
Exclusion criteria
1. Is pregnant or breast-feeding 2. Currently receiving or has within the past 2 months received radio- and/or chemotherapy 3. Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted) 4. Is currently using a convex base plate 5. Participating in other clinical studies or has previously participated in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Output Under the Base Plate (Leakage). | Each test product was assessed for 2 weeks. | Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage). |
Countries
Denmark, France, Germany, Iceland
Participant flow
Pre-assignment details
A total of 33 subjects were enrolled in the trial. Of these, 6 discontinued during the New ostomy base plate run-in period prior to period 1 and were excluded from the Intention-To-Treat analysis set (no performance data obtained). 27 subjects comprised the intention-to-treat population.
Participants by arm
| Arm | Count |
|---|---|
| Intention-to-treat Analysis Set | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 2 |
| Period 1 | E.g. study termination | 3 | 1 |
| Period 1 | Lack of Efficacy | 0 | 1 |
| Period 1 | Withdrawal by Subject | 0 | 1 |
| Period 2 | Adverse Event | 1 | 0 |
| Period 2 | E.g. study termination | 2 | 2 |
| Period 2 | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Intention-to-treat Analysis Set |
|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment Denmark | 19 participants |
| Region of Enrollment France | 6 participants |
| Region of Enrollment Germany | 1 participants |
| Region of Enrollment Iceland | 1 participants |
| Sex: Female, Male Female | 14 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 | 0 / 21 | 13 / 30 |
| serious Total, serious adverse events | 0 / 21 | 1 / 30 |
Outcome results
Primary
Degree of Output Under the Base Plate (Leakage).
Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).
Time frame: Each test product was assessed for 2 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Base Plate | Degree of Output Under the Base Plate (Leakage). | 4.6 units on a scale | Standard Deviation 3.5 |
| New Ostomy Base Plate | Degree of Output Under the Base Plate (Leakage). | 6.5 units on a scale | Standard Deviation 5 |