Healthy
Conditions
Brief summary
The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.
Detailed description
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.
Interventions
DRUGChloraPrep
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
DRUGDuraPrep
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
Sponsors
Cyberderm Inc.
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is willing to sign the Research Consent form * Healthy male or female subjects ages between 18 - 65 * Subject has agreed to be and appears to be compliant with requirements of the study * Subject has a back (the product application site) of sufficient size, free of blemishes to comfortably fit 18 strips of 1/2 x 3 drape samples * Subject is willing to have the back clipped or shaved if it has excessive hair
Exclusion criteria
* Sensitivity/allergy to adhesive products (e.g. medical tapes) * Sensitivity to the antimicrobial agent iodine, povidone iodine (PVPI), isopropyl alcohol (IPA), or chlorhexidine gluconate (CHG) * Allergy to seafood * History of psoriasis dermatitis, or any skin condition that might be exacerbated by the action of removing adhesive materials * Active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on the subject's back * History of diabetes * Subject is currently pregnant or thinks she may be pregnant or is nursing * Subject is receiving steroid-based anti-inflammatory or immunosuppressant drug therapy * Subject is taking antihistamine medication * Subject has been using moisturizers or other skin contact materials on the test sites for 24 hours prior to the start of the study * Subject has a back problem that prohibits him or her from lying face downward for approximately 2 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drape Adhesion | 30 minutes | The peel force to remove the sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | 30 minutes | Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | ChloraPrep , DuraPrep |
|---|---|
| Age, Continuous | 40.4 participants STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Drape Adhesion
The peel force to remove the sample
Time frame: 30 minutes
Population: Data analysis per protocol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ChloraPrep | Drape Adhesion | 78.6 grams-force |
| DuraPrep | Drape Adhesion | 181.3 grams-force |
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)
Time frame: 30 minutes
Population: The number of participants was determined to provide 80% power to detect a difference of 20% for the drape by prep comparisons
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ChloraPrep | Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | Skin assessment on Ioban application site | 0.67 units on a scale | Standard Deviation 0.52 |
| ChloraPrep | Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | Skin assessment on ActiGard application site | 0.31 units on a scale | Standard Deviation 0.44 |
| ChloraPrep | Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | Skin assessment on Steri-Drape 2 application site | 0.30 units on a scale | Standard Deviation 0.43 |
| DuraPrep | Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | Skin assessment on Ioban application site | 0.98 units on a scale | Standard Deviation 0.62 |
| DuraPrep | Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | Skin assessment on ActiGard application site | 0.90 units on a scale | Standard Deviation 0.65 |
| DuraPrep | Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | Skin assessment on Steri-Drape 2 application site | 0.95 units on a scale | Standard Deviation 0.58 |