Colostomy Stoma, Ileostomy - Stoma
Conditions
Brief summary
The study investigates the performance of a new adhesive with regard to the skin condition
Interventions
DEVICETest Product A
The test product is a newly developed ostomy product
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 * Have an ileostomy or a colostomy with liquid\* output (as their usual output) * Be at least 18 years of age and have full legal capacity * Have had their stoma for at least three months * Be able to use products with max cut size 45 mm * Have self-reported problems with leakage\*\* (three times within 14 days) * Handle the Clinical App, test product and comparator product themselves * Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product * Minimum change of baseplate at least once every 3rd day * Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation * Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation
Exclusion criteria
* Are currently receiving or have within the past two 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) * Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment\* (e.g. injection or tablets). * Get a positive result of a pregnancy test for women of childbearing age/fertile (\*\*clarified in section 6.3.2) * Are breast feeding * Are participating in other interventional clinical investigations or have previously participated in this investigation Exception: Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans Epidermal Water Loss | Four weeks | Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage. Trans Epidermal Water Loss is reported in grams of water per square meter per hour (g/m\^2/h). |
Countries
Denmark, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline and Test Period The users tested a product for two weeks (baseline) and then went on to try the Test Product A for 28 days. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Baseline and Test Period |
|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 10.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Denmark | 19 participants |
| Region of Enrollment Sweden | 4 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 3 / 23 | 5 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Trans Epidermal Water Loss
Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage. Trans Epidermal Water Loss is reported in grams of water per square meter per hour (g/m\^2/h).
Time frame: Four weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Comparator Product | Trans Epidermal Water Loss | 39.0 g/m^2/h |
| Test Product A | Trans Epidermal Water Loss | 35.9 g/m^2/h |