The study investigates the performance of three new adhesives with regard to leakage and the skin condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
35
SenSura Mio is a marked ostomy device which is used as the comparator in this study
Coloplast Ostomy device 1 a newly developed ostomy device
Coloplast Ostomy device 2 a newly developed ostomy device
Coloplast A/S
Humlebæk, Denmark
CCBR Vejle
Vejle, Denmark
QPS Netherlands
Groningen, Netherlands
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 aloss 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
Time frame: 14 days
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Coloplast Ostomy device 3 a newly developed ostomy device