Skin Injury Clinical Trial
Official title:
Thermotape High-adhesion Medical Tape Comparison Study
Verified date | August 2022 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This objective of this study is to compare the safety and performance of Thermotape compared to Tegaderm™ tape and Kind™ tape over the course of 24 hours.
Status | Completed |
Enrollment | 54 |
Est. completion date | July 29, 2022 |
Est. primary completion date | July 29, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: - Participants should be between 18 to 25 years of age. Exclusion Criteria: - Participants with history of eczema or medical related skin injuries (MARSI), allergic to adhesives, and/or have a wound or rash on their skin will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | University of Washington Institute for Translational Health Science (UL1 TR002319) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Experienced by Tape Removal | A 0 to 10 point Wong-Baker FACES Pain Rating Scale will be used to quantify the pain felt by the subject when each tape is removed. A score of 0 represents no pain experienced by removal, while 10 represents severe pain experienced during tape removal. | Each removal and assessment would take at maximum 5 minutes. | |
Primary | Skin Irritation | Redness of the skin will be examined after tape is removed. | Subjects will wait approximately 15 minutes before leaving, to ensure that irritation has occurred. | |
Secondary | Skin cells | The skin cells removed from the skin during tape removal will be quantified. This will be performed by staining the tape and counting the cells under a light microscope. | The removal of each tape will take a maximum of 2 minutes. | |
Secondary | Wear | The condition of the tape after 24 hours will be examined. A 0 to 7 point scale will be used to quantify the wear, with 0 representing the maximum amount of wear, where the tape strip is no longer attached, while 7 represents little to no wear, with all corners of the tape fully adhered. | The removal of each tape will take a maximum of 2 minutes. | |
Secondary | Hair Follicles | Arm hair removed from tape removal will be quantified. | The removal of each tape will take a maximum of 2 minutes. | |
Secondary | Trans-epidermal Water Loss | Water loss experienced by the epidermis after tape removal will be measured. | The removal of each tape will take a maximum of 2 minutes. |
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