Thermotape High-adhesion Medical Tape Comparison Study

Study Overview
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Brief Summary
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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.

Official Title
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Thermotape High-adhesion Medical Tape Comparison Study

Conditions
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Skin Injury

Intervention / Treatment
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* Device: Thermotape
* Device: Tegaderm
* Device: Kind


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participant<br>Tegaderm™ tape, Kind™ removal tape, and Thermotape will be applied to both of the participant's forearms. | Device: Thermotape<br>* 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.<br>Device: Tegaderm<br>* 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.<br>Device: Kind<br>* 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.<br>|
| No Intervention: Researcher<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| Hair Follicles | Arm hair removed from tape removal will be quantified. | The removal of each tape will take a maximum of 2 minutes. | 
| 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. |