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NCT05415059 Clinical Trial

LEAFix Adhesion in Healthy Volunteers

Adhesion Clinical Trial

Official title:
Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion Verification Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05415059
Other study ID # SP0935
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 10, 2022
Est. completion date November 2022

Study information
Verified date March 2022
Source Liverpool University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 32
Est. completion date November 2022
Est. primary completion date October 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Liverpool University Hospitals NHS Foundation Trust

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary 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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