Back to resultsThermotape High-adhesion Medical Tape Comparison Study
Primary Purpose
Skin Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thermotape
Tegaderm
Kind
Sponsored by
About this trial
This is an interventional other trial for Skin Injury
Eligibility Criteria
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.
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Participant
Researcher
Arm Description
Tegaderm™ tape, Kind™ removal tape, and Thermotape will be applied to both of the participant's forearms.
Outcomes
Primary Outcome Measures
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.
Skin Irritation
Redness of the skin will be examined after tape is removed.
Secondary Outcome Measures
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.
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.
Hair Follicles
Arm hair removed from tape removal will be quantified.
Trans-epidermal Water Loss
Water loss experienced by the epidermis after tape removal will be measured.
Full Information
NCT ID
NCT05449600
First Posted
July 4, 2022
Last Updated
August 29, 2022
Sponsor
University of Washington
Collaborators
University of Washington Institute for Translational Health Science (UL1 TR002319)
1. Study Identification
Unique Protocol Identification Number
NCT05449600
Brief Title
Thermotape High-adhesion Medical Tape Comparison Study
Official Title
Thermotape High-adhesion Medical Tape Comparison Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
University of Washington Institute for Translational Health Science (UL1 TR002319)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Injury
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Tegaderm™ tape, Kind™ tape, and Thermotape will be applied to both forearms for 24 hours. Afterwards, one forearm will have the tapes removed normally, without any intervention. The other forearm will have the tapes removed after heat is applied, using a heatpack.
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participant
Arm Type
Experimental
Arm Description
Tegaderm™ tape, Kind™ removal tape, and Thermotape will be applied to both of the participant's forearms.
Arm Title
Researcher
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Thermotape
Intervention Description
Thermotape will be applied along the left and right forearm. One piece of tape, one inch wide by two inches long, will be applied to each arm. The location the tape, when applied, will be randomized. Altogether, two pieces of this particular tape will be applied, one to each forearm.
Intervention Type
Device
Intervention Name(s)
Tegaderm
Intervention Description
Tegaderm™will be applied along the left and right forearm. One piece of tape, one inch wide by two inches long, will be applied to each arm. The location the tape, when applied, will be randomized. Altogether, two pieces of this particular tape will be applied, one to each forearm.
Intervention Type
Device
Intervention Name(s)
Kind
Intervention Description
Thermotape will be applied along the left and right forearm. One piece of tape, one inch wide by two inches long, will be applied to each arm. The location the tape, when applied, will be randomized. Altogether, two pieces of this particular tape will be applied, one to each forearm.
Primary Outcome Measure Information:
Title
Pain Experienced by Tape Removal
Description
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.
Time Frame
Each removal and assessment would take at maximum 5 minutes.
Title
Skin Irritation
Description
Redness of the skin will be examined after tape is removed.
Time Frame
Subjects will wait approximately 15 minutes before leaving, to ensure that irritation has occurred.
Secondary Outcome Measure Information:
Title
Skin cells
Description
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.
Time Frame
The removal of each tape will take a maximum of 2 minutes.
Title
Wear
Description
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.
Time Frame
The removal of each tape will take a maximum of 2 minutes.
Title
Hair Follicles
Description
Arm hair removed from tape removal will be quantified.
Time Frame
The removal of each tape will take a maximum of 2 minutes.
Title
Trans-epidermal Water Loss
Description
Water loss experienced by the epidermis after tape removal will be measured.
Time Frame
The removal of each tape will take a maximum of 2 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Seibel, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Thermotape High-adhesion Medical Tape Comparison Study
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