LEAFix Adhesion in Healthy Volunteers

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Adhesion
• Intervention / Treatment: Device: Covatech Stoma bag material

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Main Cohort; Cohort of healthy volunteers to have device affixed	Device: Covatech Stoma bag material; Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Liverpool University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): August 10, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: SP0935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: For internal use

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No