Stoma Ileostomy
Conditions
Brief summary
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.
Interventions
OTHERtest patch
the test patch consists of an adhesive patch
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
Yes
Inclusion criteria
1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have intact skin on the area used in the evaluation 4. Have an abdominal area accessible for application of test product (assessed by investigator) 5. Negative pregnancy test for fertile women 6. Signed document claiming use of safe contraceptives for fertile women
Exclusion criteria
1. Currently receiving or have within the past 2 month received radio- and/or chemo-therapy 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. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigator) 5. Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resistance (Moisture in the Adhesive) | 3 days | The outcome measure is described as number of events where the sensor system reacted to a false positive leak. Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Patch two adhesive patches are applied to the abdominal area
test patch: the test patch consists of an adhesive patch | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Test Patch | — |
|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Resistance (Moisture in the Adhesive)
The outcome measure is described as number of events where the sensor system reacted to a false positive leak. Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks.
Time frame: 3 days
Population: Healthy volunteers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Patch (Adhesive Patch With Sensor System) + Normal Daily Activities | Resistance (Moisture in the Adhesive) | 0 Number of false positive leaks |
| Test Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities | Resistance (Moisture in the Adhesive) | 0 Number of false positive leaks |