LEAFix Adhesion in Healthy Volunteers

Liverpool University Hospitals NHS Foundation Trust32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Adhesion

Interventions

Covatech Stoma bag materialDEVICE

Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 24 hours

Secondary Outcomes

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

Time frame: 7 days

Data from ClinicalTrials.gov

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