LEAFix Adhesion in Healthy Volunteers

Not Applicable

• Conditions: Adhesion
• Interventions: Device: Covatech Stoma bag material

• Registration Number: NCT05415059
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-08
• Study Start: 2022-08-10
• Primary Completion: 2022-10
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Healthy volunteers
• Not been in a trial in last 12 weeks
• mild to no skin issues

Read More

Exclusion Criteria

• any significant allergies
• any allergies to skin adhesive
• any medium to severe skin issues

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main Cohort	Covatech Stoma bag material	Cohort of healthy volunteers to have device affixed

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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