Adhesive Tape TraumaNCT01354106
Adhesive Tape Trauma Evaluation of Two Gentle Tapes
A study testing Skin Trauma in people with Adhesive Tape Trauma, run by Solventum US LLC at 1 site in United States.
Trial summary
The objective of this study is to determine the relative gentleness of two tapes recognized for gentleness. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used. Read more about this study
- Who is it for?
- Ages 6 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Adhesive Tape Trauma
- What is being tested?
- Skin Trauma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema
- Who are between the ages of 6 months - 4 years of age
- Who has a Fitzpatrick Skin Type of I, II or III
- Subject who's parent agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date
- Whose parent is willing to sign the Informed Consent Form.
Who cannot join
- Who are known to be developmentally delayed
- Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites
- Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study.
- Who have had a strep infection within the past 2 weeks
- Who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
- Who have allergies to isocyanates, or acrylate adhesive products
- Who currently take any antihistamines or anti-inflammatory medication or who have taken any of these medications within 48 hours prior to the start of the study or does not agree to refrain from taking these medications for the 48 hours prior to the start of the study and for the duration of the study (Tylenol is an acceptable pain reliever).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adhesive Tape Trauma Evaluation of Two Gentle Tapes in Healthy Human Infant Subjects
The objective of this study is to determine the relative gentleness of two tapes recognized for gentleness. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.
Read the detailed description
The objective of this study is to determine the relative gentleness of a new investigational tape compared to 3M Micropore tape, a gold standard tape recognized for its gentleness and used as a mainstay in cosmetic surgery and neonatal care. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.
- Conditions
- Adhesive Tape Trauma
- Being tested
- Skin Trauma
- Keywords
- Skin condition after wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin TraumaDevice
Also called 3M Micropore, 3M Kind Removal Silicone Tape - Investigational tape
Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.
| Study group | Role | What they receive |
|---|---|---|
| 3M Kind Removal Silicone Tape | Experimental | investigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Receives: Device: Skin Trauma |
| 3M Micropore Medical Tape | Other | Commercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control. Receives: Device: Skin Trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Trauma
Expert grader using Erythema/Edema Scale 0=No visible response
- mild response
- moderate response
- severe response
- extreme response
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adhesive Tape TraumaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Gary L Grove, PhD, Principal investigator, cyberDERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354106
- Sponsor's protocol ID
- EM-05-012247
- Status last verified
- Sep 2024
- First submitted
- 13 May 2011
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adhesive Tape Trauma Evaluation of Two Gentle Tapes in Healthy Human Infant Subjects
- ClinicalTrials.gov ID
- NCT01354106
- Acronym / sponsor ID
- EM-05-012247
- Conditions
- Adhesive Tape Trauma
- Keywords
- Skin condition after wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Posted 12 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the relative gentleness of two tapes recognized for gentleness. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.
Detailed description
The objective of this study is to determine the relative gentleness of a new investigational tape compared to 3M Micropore tape, a gold standard tape recognized for its gentleness and used as a mainstay in cosmetic surgery and neonatal care. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3M Kind Removal Silicone Tape | Experimental | Device: Skin Traumainvestigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours. |
| 3M Micropore Medical Tape | Other | Device: Skin TraumaCommercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control. |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema
- Who are between the ages of 6 months - 4 years of age
- Who has a Fitzpatrick Skin Type of I, II or III
- Subject who's parent agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date
- Whose parent is willing to sign the Informed Consent Form.
Key exclusion criteria (7 listed)
- Who are known to be developmentally delayed
- Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites
- Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study.
- Who have had a strep infection within the past 2 weeks
- Who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
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 |
|---|---|---|
| Skin TraumaAlso: 3M Micropore, 3M Kind Removal Silicone Tape - Investigational tapeEach participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape. | Device | 3M Kind Removal Silicone Tape, 3M Micropore Medical Tape |
Primary outcome
Skin Trauma
Time frame: 24 hours
Expert grader using Erythema/Edema Scale 0=No visible response 1. mild response 2. moderate response 3. severe response 4. extreme response
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Adhesive Tape Trauma
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Medical Adhesive and Barrier Products for Preventing MARSI in Central Venous Catheter Dressings
Medical Adhesive Related Skin Injury, Central Venous Catheter
Recruiting
To Evaluate The Skin Closure Time, Parents' Satisfaction, Post Operative Mental Health, Wound Cosmesis and Wound Complication Of Skin Closure Using Adhesive Glue, Adhesive Tape And Suture In Paediatric Surgery Patients
Skin Wound
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.
Gary L Grove, PhD principal investigator
cyberDERM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Trauma in people with Adhesive Tape Trauma, run by Solventum US LLC 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 5 inclusion and 7 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 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Skin Trauma (time frame: 24 hours). 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 Oct 2024.