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| Name | Class |
|---|---|
| Cyberderm Inc. | INDUSTRY |
| 3M | INDUSTRY |
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The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.
Adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. This study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChloraPrep | Active Comparator | Applied ChloraPrep on the application site per manufacturer's instruction |
|
| DuraPrep | Active Comparator | Apply DuraPrep to the application site per manufacturer's instruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChloraPrep | Drug | The application sites (subjects' backs) will be prepped with ChloraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule |
| Measure | Description | Time Frame |
|---|---|---|
| Drape Adhesion | The peel force to remove the sample | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction) | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary L Grove, PhD | Cyberderm Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cyberDERM Clinical Studies | Broomall | Pennsylvania | 19008 | United States |
Volunteers who met the exclusion/inclusion criteria were required to undergo a 1-day washout period where they were not allowed to use any moisturizing products or other skin contact materials on their backs. Two subjects were screen failures.
Study was conducted between 22 Feb and 5 March 2010. Twenty-four male or female healthy volunteers between ages of 18 and 65 were screened for this study in order to ensure that at least 20 volunteers were enrolled. Volunteers were recruited from a pool of suburban men/women who met the exclusion/inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | ChloraPrep, DuraPrep | Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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A sample size of 18 subjects and 18 drape samples per subject was determined to provide 80% power to detect a difference of 20% for the drape by prep comparison. A minimum of 20 subjects was used to account for the uncertainty in variability.
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| ID | Title | Description |
|---|---|---|
| BG000 | ChloraPrep , DuraPrep | Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Drape Adhesion | The peel force to remove the sample | Data analysis per protocol | Posted | Mean | 95% Confidence Interval | grams-force | 30 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ChloraPrep, DuraPrep | Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule |
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All 22 subjects enrolled completed the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary Grove | cyberDERM Clinical Studies | 610-325-0112 |
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| ID | Term |
|---|---|
| C515331 | DuraPrep |
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| DuraPrep | Drug | The application sites (subjects' backs) will be prepped with DuraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule |
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| participants |
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| Sex: Female, Male | Eleven males and 11 females were enrolled into the study | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction) | The number of participants was determined to provide 80% power to detect a difference of 20% for the drape by prep comparisons | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
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| 0 |
| 22 |
| 0 |
| 22 |
Restriction for PI to publish trial results without review and approval by sponsor
| Skin assessment on Steri-Drape 2 application site |
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