Ileostomy - Stoma
Conditions
Brief summary
This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.
Interventions
DEVICEOstomy device 1
This device consists of a known adhesive and a new top film
DEVICEOstomy device 2
This device consists of a new adhesive and a known top film
DEVICEOstomy device 3
This device consists of a known adhesive and a new top film
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have given written informed consent and in DK: signed a letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Have had their ileostomy for at least 3 months 4. Have an ileostomy with a diameter between 10 and 55 mm 5. Be able to handle the Clinical App. and product themselves 6. Must be able to use custom cut product 7. Minimum change of product every second day 8. If current product is SenSura Mio - Be willing to use Maxi bag during investigation 9. Subject using Sensura or Sensura Mio flat 1 pc. open for at least two weeks before inclusion in the study. 10. Negative result of a pregnancy test for women of childbearing age (only DK)
Exclusion criteria
1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis) 2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed. 3. Are pregnant or breastfeeding\*\* 4. Are participating in other interventional clinical investigations or have previously participated in this investigation 5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator) 6. Have known hypersensitivity towards any of the products used in the investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans Epidermal Water Loss | 7 days | The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m\^2/h). |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ostomy Device 1 In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film | 13 |
| Ostomy Device 2 In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film | 15 |
| Ostomy Device 3 In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film | 10 |
| Total | 38 |
Baseline characteristics
| Characteristic | Ostomy Device 2 | Ostomy Device 3 | Total | Ostomy Device 1 |
|---|---|---|---|---|
| Age, Continuous | 70.1 years STANDARD_DEVIATION 7.7 | 63.6 years STANDARD_DEVIATION 13 | 68.4 years STANDARD_DEVIATION 9.2 | 70.1 years STANDARD_DEVIATION 6.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Denmark | 15 participants | 10 participants | 38 participants | 13 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 13 Participants | 7 Participants | 31 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 15 | 0 / 10 |
| other Total, other adverse events | 2 / 13 | 1 / 15 | 1 / 10 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 | 0 / 10 |
Outcome results
Primary
Trans Epidermal Water Loss
The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m\^2/h).
Time frame: 7 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ostomy Device 1 | Trans Epidermal Water Loss | 19.6 g/m^2/h |
| Ostomy Device 2 | Trans Epidermal Water Loss | 20.7 g/m^2/h |
| Ostomy Device 3 | Trans Epidermal Water Loss | 24.1 g/m^2/h |