Adhesive Tape Trauma
Conditions
Keywords
Skin condition after wear
Brief 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.
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.
Interventions
DEVICESkin Trauma
Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
Yes
Inclusion criteria
1. Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema 2. Who are between the ages of 6 months - 4 years of age 3. Who has a Fitzpatrick Skin Type of I, II or III 4. 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 5. Whose parent is willing to sign the Informed Consent Form.
Exclusion criteria
1. Who are known to be developmentally delayed 2. Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites 3. 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. 4. Who have had a strep infection within the past 2 weeks 5. Who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions 6. Who have allergies to isocyanates, or acrylate adhesive products 7. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Trauma | 24 hours | Expert grader using Erythema/Edema Scale 0=No visible response 1. mild response 2. moderate response 3. severe response 4. extreme response |
Countries
United States
Participant flow
Recruitment details
recruitment started May 16, 2011 at cyberDERM
Pre-assignment details
participant not to use any products on the test sites for 24 hours prior to the study state date.
Participants by arm
| Arm | Count |
|---|---|
| Infant Investigational adhesive tape control paper tape | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Infant |
|---|---|
| Age, Categorical <=18 years | 26 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 2.88 years STANDARD_DEVIATION 0.87 |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Skin Trauma
Expert grader using Erythema/Edema Scale 0=No visible response 1. mild response 2. moderate response 3. severe response 4. extreme response
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M Kind Removal Silicone Tape | Skin Trauma | 0.93 Units on a scale | Standard Deviation 0.14 |
| 3M Micropore Medical Tape | Skin Trauma | 1.35 Units on a scale | Standard Deviation 0.11 |