LEAFix Adhesion in Healthy Volunteers

Liverpool University Hospitals NHS Foundation Trust

Status: Unknown

Conditions: Adhesion

Treatments: Device: Covatech Stoma bag material

Study type: Interventional

Funder types: Other

Identifiers

NCT05415059

SP0935

Details and patient eligibility

About

This study compares the adhesiveness of the 3M material to be used in the final design.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Main Cohort

Other group

Description:

Cohort of healthy volunteers to have device affixed

Treatment:

Device: Covatech Stoma bag material