Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion
Research type
Research Study
Full title
Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion
IRAS ID
316855
Contact name
Richard Ramsaran
Contact email
Sponsor organisation
Liverpool University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
The LEAFix device has been designed to improve patient care when securing an airway device in place. Current practice are reusable ties and single roll tape. The advantages are of a single use product that improves safety around the management of airway devices.
In order to CE mark the design and materials a study needs to be performed on human participants to investigate the adhesiveness of the 3M material used in the LEAFix device.
To do this strips of the 3M material currently used in a CE marked stoma bag are being used to test adhesiveness after 10 minutes and 24 hours on the arm and the face (Intended place of use). Adhesiveness is measured using a force gauge measurement for force required to remove the strip from the participant. The results will be compared to laboratory based studies on metal. We will also asses for any adverse skin outcomes.
This study will be done in patients, as the industry calculations are that these are the number of patients required to demonstrate adhesiveness and safety as compared to the previous non human testing.
This study is funded by Innovel Ltd. the manufacturer and distributor of the LEAFix device.
The CE marked product is for use on the skin.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0176
Date of REC Opinion
28 Sep 2022
REC opinion
Further Information Favourable Opinion