Colostomy, Ileostomy - Stoma
Conditions
Brief summary
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
Detailed description
72 subjects will be included. Each subject will attend 3 visits at the clinic/hospital or at the subjects home depending on the final site set-up. Each subject will be enrolled for 14 weeks in total for the entire investigation. Coloplast will provide SenSura Mio Convex Soft for all subjects via the investigator. Based on the subjects' usual changing pattern, the investigator will provide the subjects with enough products for the whole test period. The subject will answer questions regarding the tested products by filling out the subject part in the eCRF daily. The subject will answer questions using an electronic device and use the device to take pictures of the peristomal skin and used products at each product change. The Investigator fills out the investigator part of the eCRF at each visit. The subjects must complete the general questions at the end of each test period before their second and third visit at the Clinic/hospital or at home to avoid influence by the investigator. The use of accessories will be noted in the eCRF. Samples of biological material will not be taken or used in this investigation. Patient files from own physician will not be used for subjects recruited via a Coloplast's database. The investigators may use patient files for subjects recruited via hospital sites/ostomy clinics to identifying relevant subjects and/or to verify baseline information, concomitant medication or adverse events. To be able to fulfil the objectives, the investigation must include both ileostomists and colostomists.
Interventions
DEVICESenSura Mio Convex Soft
SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have given written informed consent * Be at least 18 years of age and have full legal capacity * Have an ileostomy or colostomy * Have had their ostomy for at least 3 months * Must use 1 piece open or closed ostomy products during the test period * Currently using a 1 piece. flat product * Must be able to use custom cut product * Have intact peristomal skin * Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks * Are evaluated to be suitable for a soft convex product
Exclusion criteria
* Currently receiving or have within the past 2 month received radio- and/or chemotherapy * Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. * Are pregnant or breastfeeding * Participating in other interventional clinical investigations or have previously participated in this investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage Under the Baseplate (cm^2) | 14 weeks (2 weeks baseline + 12 weeks intervention) | The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area. |
Countries
Netherlands, Norway, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Period The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft)
SenSura Mio Convex Soft: SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast | 73 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Baseline Period (Own Product) | Protocol Violation | 1 |
| Test Period (SenSura Mio Convex Soft) | Adverse Event | 3 |
| Test Period (SenSura Mio Convex Soft) | Lack of Efficacy | 2 |
| Test Period (SenSura Mio Convex Soft) | One subjects was not suited for the tes | 2 |
| Test Period (SenSura Mio Convex Soft) | Protocol Violation | 1 |
| Test Period (SenSura Mio Convex Soft) | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Test Period |
|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 71 |
| other Total, other adverse events | 17 / 74 | 25 / 71 |
| serious Total, serious adverse events | 0 / 74 | 1 / 71 |
Outcome results
Primary
Leakage Under the Baseplate (cm^2)
The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area.
Time frame: 14 weeks (2 weeks baseline + 12 weeks intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Own Product | Leakage Under the Baseplate (cm^2) | 9.2 cm2 | Standard Deviation 9.8 |
| SenSura Mio Convex Soft | Leakage Under the Baseplate (cm^2) | 6.6 cm2 | Standard Deviation 8.2 |