Ileostomy
Conditions
Brief summary
The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.
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
* Have given written informed consent and letter of authority * Be at least 18 years of age and have full legal capacity * Be able to handle the products her/himself * Have an ileostomy with a diameter between 10 and 30 mm * Willing to follow the product change schedule (one change per day) * Have had their ostomy for at least three months * Willing to use 1 piece open ostomy products during the test period * Must be able to use a custom cut product * Have intact skin * Negative result of a pregnancy test for women of childbearing age
Exclusion criteria
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy * Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment * Is pregnant or breastfeeding. * Is participating in other interventional clinical investigations or have previously participated in this investigation * Have a loop ileostomy * Known hypersensitivity towards any of the test products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product Acceptance | 7 days per test period | Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population The investigation is a cross-over investigation therefore baseline data is presented for the overall population | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 2 |
| Period 1 | Lack of Efficacy | 0 | 1 |
| Period 2 | Adverse Event | 0 | 2 |
| Period 2 | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Continuous | 57.0 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 10 | 3 / 10 | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Product Acceptance
Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product
Time frame: 7 days per test period
Population: One subject did not answer the preference question.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test A | Product Acceptance | 0 participants |
| Test B | Product Acceptance | 1 participants |