Adhesion Properties of Wound Care Devices
Conditions
Brief summary
Molnlycke manufactures and markets self-adhesive wound care devices intended to protect various types of wounds during treatment. This study aims to measure and evaluate the adhesion properties of self-adhesive wound care devices. To measure the adhesion properties test strips will be applied to the participant's skin for a predetermined time and will be removed while measuring the adhesion properties afterwards. This method has been chosen since there is no in vitro method available that can simulate adhesion to human skin
Interventions
OTHERself-adhesive device
Test device which is self-adhesive
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
all participants will receive the same up to 12 test samples, which are randomized intra-individual.
Intervention model description
intra-individual test with up 12 test samples per study run; this treatment is announced here as single group study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
Yes
Inclusion criteria
* Confirmed eligibility and signed consent form.
Exclusion criteria
* Known plaster allergy or other known contact hypersensitivity * Pregnant or breastfeeding individual.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peel Off Force | up to 48 hours | Internal machine shall measure the peel force expressed in Newton. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humidity | up to 48 hours | Humidity shall be evaluated using tactile and visual assessment |
| Redness | up to 48 hours | Visual assessment of redness of the skin |
| Pain assessment | up to 48 hours | Visual analog scale (VAS) assessment of pain after removal. The scale is 100mm long whether 0mm means no pain and 100mm means the maximum pain a participant could imagine. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Loosening | up to 48 hours | Assessment if the device is still in place or has been fallen of. |
| Comments | up to 48 hours | Further comments (not related to the other outcomes) by the participant or the investigator |
| Adhesive residuals | up to 48 hours | Adhesive residuals on the skin |
Countries
Sweden
Contacts
Primary ContactMatthew Malone, PhD
Outcome results
None listed