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Completed

NCT Number: NCT05449600

Thermotape High-adhesion Medical Tape Comparison Study

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.

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Key information

Conditions

Skin Injury

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermotape

Device

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.

Tegaderm

Device

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.

Kind

Device

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 outcomes

  1. Pain Experienced by Tape Removal

    Time frame: Each removal and assessment would take at maximum 5 minutes.

    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.

  2. Skin Irritation

    Time frame: Subjects will wait approximately 15 minutes before leaving, to ensure that irritation has occurred.

    Redness of the skin will be examined after tape is removed.

Secondary outcomes

  1. Skin cells

    Time frame: The removal of each tape will take a maximum of 2 minutes.

    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.

  2. Wear

    Time frame: The removal of each tape will take a maximum of 2 minutes.

    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.

  3. Hair Follicles

    Time frame: The removal of each tape will take a maximum of 2 minutes.

    Arm hair removed from tape removal will be quantified.

  4. Trans-epidermal Water Loss

    Time frame: The removal of each tape will take a maximum of 2 minutes.

    Water loss experienced by the epidermis after tape removal will be measured.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • University of Washington Institute for Translational Health Science (UL1 TR002319)

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2022
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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