Thermotape High-adhesion Medical Tape Comparison Study

Skin Injury Clinical Trial

Official title:

Thermotape High-adhesion Medical Tape Comparison Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449600
• Other study ID #: STUDY00014704
• Secondary ID: U01HL152401
• Status: Completed
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: July 29, 2022

Study information

• Verified date: August 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Injury
• Tissue Adhesions

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	University of Washington Institute for Translational Health Science (UL1 TR002319)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	Hair Follicles	Arm hair removed from tape removal will be quantified.	The removal of each tape will take a maximum of 2 minutes.
Secondary	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.