Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 3M | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M Kind Removal Silicone Tape | Experimental | investigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours. |
|
| 3M Micropore Medical Tape | Other | Commercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Trauma | Device | Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Trauma | Expert grader using Erythema/Edema Scale 0=No visible response
| 24 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gary L Grove, PhD | cyberDERM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cyberDERM | Broomall | Pennsylvania | 19008 | United States |
participant not to use any products on the test sites for 24 hours prior to the study state date.
recruitment started May 16, 2011 at cyberDERM
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adhesive Medical Tape | Each study participant received both treatment arms: 3M Kind Removal Silicone Tape (1" x 1.5" sample, applied one time, worn 24 hours) and 3M Micropore Silicone Tape (1" x 1.5" sample, applied one ime, worn 24 hours). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Infant | Investigational adhesive tape control paper tape |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skin Trauma | Expert grader using Erythema/Edema Scale 0=No visible response
| Posted | Mean | Standard Deviation | Units on a scale | 24 hours |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational Adhesive Tape |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary Grove | cyberDERM | 610-325-0112 | GGrove@cyberderm-inc.com |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Control Paper Tape | 0 | 26 | 0 | 26 |
The proposed disclosure must be reviewed by the sponsor. The sponsor shall complete the review within 30 working days after receipt. The PI will discuss and consider in good faith the sponsor recommendations resulting from the review.