Ileostomy - Stoma
Conditions
Brief summary
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
Detailed description
The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.
Interventions
DEVICEColoplast test product
Coloplast test product is a newly developed 2-piece ostomy appliance
DEVICESenSura
SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from 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.Have given written informed consent and letter of authority (DK only) * 2.Be at least 18 years of age and have full legal capacity. * 3.Be able to handle the products her/himself * 4.Have an ileostomy with a diameter between 10 and 40 mm. * 5.Have had their ostomy for at least three months. * 6.Be willing to use minimum 2 base plates every week * 7.Currently use 2-piece flat mechanical coupling product with open bag 8 * 11.Negative result of a pregnancy test for women of childbearing age (only DK)
Exclusion criteria
* 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy. * 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. * 3.Is pregnant or breastfeeding. * 4.Is participating in other interventional clinical investigations or have previously participated in this investigation * 5.Has participated in the previous explorative study CP234 * 6\. * 7.Known hypersensitivity towards any of the test products * 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preference | 21+1 days | The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura. |
Countries
Belgium, Denmark, Netherlands, Norway, Sweden
Participant flow
Recruitment details
The subjects were recruited from Coloplast user data base, from hospital sites and stoma care sites.
Pre-assignment details
130 subjects were randomised, however 3 of these were not exposed to a product and where not included in the safety population. The participant flow below is generated based on the safety population.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects baseline data are summarized for all subjects | 125 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Test Period 1 (21 +- 1 Days) | Adverse Event | 2 | 0 |
| Test Period 1 (21 +- 1 Days) | Lack of Efficacy | 2 | 3 |
| Test Period 1 (21 +- 1 Days) | screen failure | 1 | 0 |
| Test Period 1 (21 +- 1 Days) | Withdrawal by Subject | 2 | 0 |
| Test Period 2 (21 +- 1 Days) | Adverse Event | 1 | 3 |
| Test Period 2 (21 +- 1 Days) | completed early by mistake | 0 | 1 |
| Test Period 2 (21 +- 1 Days) | device deficiency without AE | 0 | 1 |
| Test Period 2 (21 +- 1 Days) | Lack of Efficacy | 1 | 2 |
| Test Period 2 (21 +- 1 Days) | Other | 1 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 124 | 22 / 120 |
| serious Total, serious adverse events | 4 / 124 | 1 / 120 |
Outcome results
Primary
Preference
The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.
Time frame: 21+1 days
Population: The ITT population was constituted by all randomized subjects with valid informed consent who had applied at least one test product and had valid information for the primary endpoint preference, or valid information for at least one product with respect to one of the secondary endpoints., who included all subject who contributed with endpoint data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coloplast Test Product | Preference | 65 percentage of participants |
| SenSura | Preference | 35 percentage of participants |