Adhesion
Conditions
Brief summary
This study compares the adhesiveness of the 3M material to be used in the final design.
Detailed description
The material is taken from a CE marked stoma bag. Strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. A force gauge will measure the peel force. This will be compared to previous testing on metal. Participants will also be assessed and followed up for any adverse skin issues.
Interventions
DEVICECovatech Stoma bag material
Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device
Sponsors
Liverpool University Hospitals NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * Not been in a trial in last 12 weeks * mild to no skin issues
Exclusion criteria
* any significant allergies * any allergies to skin adhesive * any medium to severe skin issues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adhesion after 24 hours | 24 hours | Adhesion after 24 hours of placement inferred from peel force measured with a force gauge at 10 minutes and 24 hours measured in Newtons (N) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin outcomes | 7 days | Asses for any issues with adhesion to the skin with a questionnaire on day 7 - likehart scale for different skin parameters ie. degree of itchiness with 0 being none and 3 being severe |
Outcome results
None listed