Thermotape High-adhesion Medical Tape Comparison Study

NCT05449600 | Completed FDA Device

• 2 other identifiers: STUDY00014704U01HL152401
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Skin cells

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

• Wear

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

• Hair Follicles

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

• Trans-epidermal Water Loss

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

Study Arms (2)

Participant

EXPERIMENTAL

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

Device: Thermotape; Device: Tegaderm; Device: Kind

Researcher

NO INTERVENTION

Interventions

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.

Participant

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.

Participant

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.

Participant

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Study Officials

• Eric J Seibel, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor: Mechanical Engineering

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: June 28, 2022
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

US (1)