Skin InjuryNCT05449600
Thermotape High-adhesion Medical Tape Comparison Study
A study testing Thermotape, Tegaderm and Kind in people with Skin Injury, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Injury
- What is being tested?
- Thermotape, Tegaderm and Kind
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2022to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants should be between 18 to 25 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Skin Injury
- Being tested
- Thermotape, Tegaderm, Kind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermotapeDevice
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.
TegadermDevice
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.
KindDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Participant | Experimental | Tegaderm™ tape, Kind™ removal tape, and Thermotape will be applied to both of the participant's forearms. Receives: Device: Thermotape; Device: Tegaderm; Device: Kind |
| Researcher | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each removal and assessment would take at maximum 5 minutes.
Skin Irritation
Redness of the skin will be examined after tape is removed.
Measured: Subjects will wait approximately 15 minutes before leaving, to ensure that irritation has occurred.
Secondary outcomes (4)
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.
Measured: 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.
Measured: The removal of each tape will take a maximum of 2 minutes.
Hair Follicles
Arm hair removed from tape removal will be quantified.
Measured: 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.
Measured: The removal of each tape will take a maximum of 2 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start28 Jun 2022
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington Institute for Translational Health Science (UL1 TR002319)
- Responsible party
- Principal investigator, Eric Seibel, University of Washington
- Investigators
- Eric J Seibel, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449600
- Sponsor's protocol ID
- STUDY00014704
- Other IDs
- U01HL152401
- Status last verified
- Aug 2022
- First submitted
- 4 Jul 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermotape High-adhesion Medical Tape Comparison Study
- ClinicalTrials.gov ID
- NCT05449600
- Acronym / sponsor ID
- STUDY00014704
- Conditions
- Skin Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of Washington Institute for Translational Health Science (UL1 TR002319)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participant | Experimental | Device: Thermotape, Device: Tegaderm, Device: KindTegaderm™ tape, Kind™ removal tape, and Thermotape will be applied to both of the participant's forearms. |
| Researcher | No intervention | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants should be between 18 to 25 years of age.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermotapeThermotape 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 | Participant |
| TegadermTegaderm™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 | Participant |
| KindThermotape 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 | Participant |
Primary outcome
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.
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.
4 secondary outcomes
Skin cells
Time frame: The removal of each tape will take a maximum of 2 minutes.
Wear
Time frame: The removal of each tape will take a maximum of 2 minutes.
Hair Follicles
Time frame: The removal of each tape will take a maximum of 2 minutes.
Trans-epidermal Water Loss
Time frame: The removal of each tape will take a maximum of 2 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Seibel, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermotape, Tegaderm and Kind in people with Skin Injury, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Experienced by Tape Removal (time frame: Each removal and assessment would take at maximum 5 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.