Stoma Ileostomy
Conditions
Brief summary
The aim of the investigation was to investigate the performance and safety of a new ostomy product.
Interventions
DEVICEColoplast test product
The Coloplast test product is a newly developed ostomy appliance
DEVICESenSura Convex Light
The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
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. Are at least 18 years of age and have full legal capacity. 2. Has had an ileostomy for at least 3 months. 3. Has used a convex ostomy product for the last month. 4. Has given signed informed consent. 5. Has experienced seeping under the baseplate at least three times during the last two weeks. 6. Currently using a SenSura Convex product with midi, maxi or magnum bags. 7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling (click coupling). 8. Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.
Exclusion criteria
1. Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets). 2. Are pregnant or breastfeeding. 3. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy. 4. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area. 5. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin. 6. Are currently participating in another clinical intervention study or have previously participated in this one. 7. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate. 8. Has known hypersensitivity toward the test product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Leakage | 28 +/- 3 days | The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate). |
Countries
Denmark, France, Germany, Norway, United Kingdom
Participant flow
Pre-assignment details
129 subjects were randomized, but two of these subjects were not exposed to a product: one subject had a stoma diameter of 42 mm (violation to inclusion criteria no.8) and one subject had chemotherapy planned (exclusion criteria no.3). 127 subjects were therefore included in the ITT population.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study The investigation is a cross-over investigation therefore the baseline data is given for the overall study population | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Test Period 1 | Adverse Event | 2 | 1 |
| Test Period 1 | bag too small | 1 | 0 |
| Test Period 1 | device deficiency with adverse event | 0 | 1 |
| Test Period 1 | Lack of Efficacy | 0 | 1 |
| Test Period 1 | Withdrawal by Subject | 3 | 0 |
| Test Period 2 | Lack of Efficacy | 0 | 1 |
| Test Period 2 | Other | 0 | 3 |
| Test Period 2 | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 14.1 |
| Gender Female | 77 participants |
| Gender Male | 49 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 125 | 14 / 120 |
| serious Total, serious adverse events | 6 / 125 | 3 / 120 |
Outcome results
Primary
Degree of Leakage
The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).
Time frame: 28 +/- 3 days
Population: The results presented above are the intention-to-treat results that were analysed as randomised. However, the adverse events are reported as treated and as 4 subjects did not follow the randomisation order there is a slight discrepancy between the participants number in the outcome and adverse events section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coloplast Test Product | Degree of Leakage | 5.1 units on a scale | Standard Deviation 5.8 |
| SenSura Convex Light | Degree of Leakage | 5.8 units on a scale | Standard Deviation 5.8 |