Adhesive Tape Trauma Evaluation of Two Gentle Tapes

Solventum US LLC

Status: Completed

Conditions: Adhesive Tape Trauma

Treatments: Device: Skin Trauma

Study type: Interventional

Funder types: Industry

Identifiers

NCT01354106

EM-05-012247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 6 months to 4 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

3M Kind Removal Silicone Tape

Experimental group

Description:

investigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours.

Treatment:

Device: Skin Trauma

3M Micropore Medical Tape

Other group

Description:

Commercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control.

Treatment:

Device: Skin Trauma