Surgical Skin Preparation, Surgical Procedure, Unspecified
Conditions
Keywords
surgical skin prep, CHG, IPA
Brief summary
This study evaluates reduction of resident flora produced by the test product within a defined prepped area of skin.
Detailed description
Three different sample sites within a defined prepped area of skin were collected to determine whether reductions in resident flora produced by the test product are consistent.
Interventions
DRUG3M CHG/IPA Prep
Apply topically to intact skin
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male subjects of any race who are at least 18 years of age, * Subjects must have an area on their back region to accommodate the treatment coverage area, * Subjects must be in good general health, * Subjects who satisfy all inclusion/
Exclusion criteria
and will voluntarily read and sign the Informed Consent Form, * Subjects who have good skin condition on the test sites, * Subjects who are willing to report to the study facility approximately 72 hours prior to Screening or Treatment Day for clipping, if needed, * Subjects who are willing to avoid showering and tub-bathing within 72 hours prior to Screening and Treatment Days, and * Subjects who have Screening Day baseline counts of \> 3.00 log10 per cm2 in each of the 3 sample sites (center, mid-peripheral and peripheral) in the treatment area (back region).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time. | Post-treatment sampling randomized as 10-minute or 13-minute post-product application | The primary measure of efficacy is change in skin flora log10 CFU/cm\^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm\^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome Evaluated by Skin Irritation Assessment | Assessed pre-treatment (baseline) and post-treatment (10 or 13 minutes) | Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0 = no reaction, 1 = mild reaction, 2 = moderate reaction, 3 = severe reaction. |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3M CHG/IPA Prep / Center Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | 3M CHG/IPA Prep / Center |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Evaluable Treatment Day Baseline Count Evaluable Subjects | 20 Participants |
| Evaluable Treatment Day Baseline Count Non-evaluable Subjects | 8 Participants |
| Race/Ethnicity, Customized Ethnicity - Hispanic or Latino | 0 participants |
| Race/Ethnicity, Customized Ethnicity - Not Hispanic or Latino | 28 participants |
| Race/Ethnicity, Customized Race - American Indian or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Race - Asian | 0 participants |
| Race/Ethnicity, Customized Race - Black or African American | 0 participants |
| Race/Ethnicity, Customized Race - More than one race | 0 participants |
| Race/Ethnicity, Customized Race - Native Hawaiian or Other Pacific Islander | 0 participants |
| Race/Ethnicity, Customized Race - Unknown or not reported | 0 participants |
| Race/Ethnicity, Customized Race - White | 28 participants |
| Sex/Gender, Customized Female | 0 participants |
| Sex/Gender, Customized Male | 28 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 | 0 / 28 |
Outcome results
Primary
Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time.
The primary measure of efficacy is change in skin flora log10 CFU/cm\^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm\^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis.
Time frame: Post-treatment sampling randomized as 10-minute or 13-minute post-product application
Population: The primary analysis data set used a Modified Intent to Treat population: Subjects were excluded who did not meet the baseline requirement of greater than or equal to 3.0 log10 CFU/cm2 in all three sampling sites on the treatment site. The sampling time for efficacy evaluation was 10 minutes or 13 minutes post-product application as per the randomization schedule.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M CHG/IPA Prep / Center | Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time. | -2.19 log10 CFU/cm^2 | Standard Deviation 1.31 |
| 3M CHG /IPA Prep - Mid-peripheral | Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time. | -1.85 log10 CFU/cm^2 | Standard Deviation 1.57 |
| 3M CHG/IPA Prep - Peripheral | Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time. | -2.42 log10 CFU/cm^2 | Standard Deviation 1.2 |
p-value: 0.34ANOVA
Other Pre-specified
Safety Outcome Evaluated by Skin Irritation Assessment
Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0 = no reaction, 1 = mild reaction, 2 = moderate reaction, 3 = severe reaction.
Time frame: Assessed pre-treatment (baseline) and post-treatment (10 or 13 minutes)
Population: All treated subjects were considered evaluable for safety. Safety assessments were based on evaluations for skin reactions at the test sites.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3M CHG/IPA Prep / Center | Safety Outcome Evaluated by Skin Irritation Assessment | Dryness - pre-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep / Center | Safety Outcome Evaluated by Skin Irritation Assessment | Dryness - post-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep / Center | Safety Outcome Evaluated by Skin Irritation Assessment | Edema - pre-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep / Center | Safety Outcome Evaluated by Skin Irritation Assessment | Edema - post-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep / Center | Safety Outcome Evaluated by Skin Irritation Assessment | Erythema - pre-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep / Center | Safety Outcome Evaluated by Skin Irritation Assessment | Erythema - post-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep / Center | Safety Outcome Evaluated by Skin Irritation Assessment | Rash - pre-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep / Center | Safety Outcome Evaluated by Skin Irritation Assessment | Rash - post-treatment rating = 0 | 28 participants |
| 3M CHG /IPA Prep - Mid-peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Edema - pre-treatment rating = 0 | 28 participants |
| 3M CHG /IPA Prep - Mid-peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Rash - pre-treatment rating = 0 | 28 participants |
| 3M CHG /IPA Prep - Mid-peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Edema - post-treatment rating = 0 | 28 participants |
| 3M CHG /IPA Prep - Mid-peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Erythema - pre-treatment rating = 0 | 28 participants |
| 3M CHG /IPA Prep - Mid-peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Erythema - post-treatment rating = 0 | 28 participants |
| 3M CHG /IPA Prep - Mid-peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Dryness - pre-treatment rating = 0 | 28 participants |
| 3M CHG /IPA Prep - Mid-peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Dryness - post-treatment rating = 0 | 28 participants |
| 3M CHG /IPA Prep - Mid-peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Rash - post-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep - Peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Edema - pre-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep - Peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Dryness - post-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep - Peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Dryness - pre-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep - Peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Edema - post-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep - Peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Rash - pre-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep - Peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Erythema - post-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep - Peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Erythema - pre-treatment rating = 0 | 28 participants |
| 3M CHG/IPA Prep - Peripheral | Safety Outcome Evaluated by Skin Irritation Assessment | Rash - post-treatment rating = 0 | 28 participants |