Thermotape High-adhesion Medical Tape Comparison Study

Not Applicable

Completed

• Conditions: Skin Injury
• Interventions: Device: Thermotape; Device: Tegaderm; Device: Kind

• Registration Number: NCT05449600
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-28
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-08
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Participants should be between 18 to 25 years of age.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Participant	Thermotape	Tegaderm™ tape, Kind™ removal tape, and Thermotape will be applied to both of the participant's forearms.
Participant	Tegaderm	Tegaderm™ tape, Kind™ removal tape, and Thermotape will be applied to both of the participant's forearms.
Participant	Kind	Tegaderm™ tape, Kind™ removal tape, and Thermotape will be applied to both of the participant's forearms.

Primary Outcome Measures

Name	Time	Method
Pain Experienced by Tape Removal	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.
Skin Irritation	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 Outcome Measures

Name	Time	Method
Trans-epidermal Water Loss	The removal of each tape will take a maximum of 2 minutes.	Water loss experienced by the epidermis after tape removal will be measured.
Wear	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.
Hair Follicles	The removal of each tape will take a maximum of 2 minutes.	Arm hair removed from tape removal will be quantified.
Skin cells	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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States