Leakage
Conditions
Brief summary
This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.
Interventions
DEVICEtest product 1: new ostomy base plate with Coloplast as manufacturer
test product 1 is tested first
DEVICEtest product 2: new ostomy base plate with Coloplast as manufacturer
test product 2 is tested first
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years. 2. Have had an ileostomy for more than 3 months. 3. Have used convex products for the last 1 month. 4. Has given written Informed Consent. 5. Have an ileostomy with a diameter between 15 and 33 mm. 6. Have inward peristomal area
Exclusion criteria
1. Have loop ostomy 2. Pregnant or breastfeeding. 3. Known allergy towards any of the product components or ingredients. 4. Currently receiving or have within the last 2 months received radio- and/or chemotherapy. 5. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area. 6. Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage Under the Base Plate Using a 24-point Scale | Each product will be tested 2 weeks | Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome) |
Countries
Denmark
Participant flow
Recruitment details
The subjects were recruited through the Coloplast database.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline Period | Adverse Event | 0 | 1 |
| Test Period 1 | Adverse Event | 1 | 0 |
| Test Period 2 | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 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 | 8 / 19 | 6 / 18 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 1 / 20 |
Outcome results
Primary
Leakage Under the Base Plate Using a 24-point Scale
Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)
Time frame: Each product will be tested 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product 1 | Leakage Under the Base Plate Using a 24-point Scale | 4.5 units on a scale | Standard Deviation 5.3 |
| Test Product 2 | Leakage Under the Base Plate Using a 24-point Scale | 3.3 units on a scale | Standard Deviation 4.3 |
| Baseline | Leakage Under the Base Plate Using a 24-point Scale | 4.4 units on a scale | Standard Deviation 4.7 |