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This study compares the adhesiveness of the 3M material to be used in the final design.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Cohort | Other | Cohort of healthy volunteers to have device affixed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covatech Stoma bag material | Device | Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion after 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) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Skin outcomes | 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 | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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For internal use
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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