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.

Study Overview

• Status: Completed
• Conditions: Skin Injury
• Intervention / Treatment: Device: Thermotape; Device: Tegaderm; Device: Kind

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Participant; Tegaderm™ tape, Kind™ removal tape, and Thermotape will be applied to both of the participant's forearms.	Device: Thermotape; 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.; Device: Tegaderm; 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.; Device: Kind; 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.
NO_INTERVENTION: Researcher

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: University of Washington Institute for Translational Health Science (UL1 TR002319)
• Investigators: Principal Investigator: Eric J Seibel, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 28, 2022
• Primary Completion (ACTUAL): July 29, 2022
• Study Completion (ACTUAL): July 29, 2022

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (ACTUAL): July 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: STUDY00014704; U01HL152401 (NIH)

Drug and device information, study documents

• 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