Surgical Skin Preparation
Conditions
Brief summary
The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.
Detailed description
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2. Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used. Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.
Interventions
DRUGCHG/IPA Surgical skin preparation
Apply topically to the inguinal region for 2 minutes
DRUGNormal saline
Apply topically to the inguinal region for 2 minutes
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects of any race * Subjects in good health * Minimum skin flora baseline requirements on inguinal region
Exclusion criteria
* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area * Topical antimicrobial exposure within 14 days prior to screening and treatment days * Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | 10 minutes | Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora |
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | 6 hours | Persistent efficacy endpoint which is a binary endpoint with success/failure, where success is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora |
Countries
United States
Participant flow
Pre-assignment details
This is a randomized, paired-comparison design where each subject received two of the planned treatments, one on the left side and one on the right. Each subject provided two inguinal test sites, left and right. 154 subjects were randomized for the inguinal region resulting in 308 applications of test products.
Participants by arm
| Arm | Count |
|---|---|
| CHG/IPA Surgical Skin Preparation Apply topically to the inguinal region for 2 minutes | 135 |
| CHG/IPA Surgical Skin Preparation Apply topically to the inguinal region for 2 minutes | 135 |
| CHG/IPA Film-Forming Surgical Skin Preparation Apply topically to the inguinal region for 2 minutes | 135 |
| CHG/IPA Film-Forming Surgical Skin Preparation Apply topically to the inguinal region for 2 minutes | 135 |
| Normal Saline Apply topically to the inguinal region for 2 minutes | 38 |
| Normal Saline Apply topically to the inguinal region for 2 minutes | 38 |
| Total | 616 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not meet treatment day baseline | 30 | 28 | 7 |
| Overall Study | Did not return for final sample collection | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | CHG/IPA Surgical Skin Preparation | CHG/IPA Film-Forming Surgical Skin Preparation | Normal Saline |
|---|---|---|---|---|
| Age, Customized > 65 years | 18 Test sites on skin | 9 Test sites on skin | 9 Test sites on skin | 0 Test sites on skin |
| Age, Customized Between 18-65 years | 290 Test sites on skin | 126 Test sites on skin | 126 Test sites on skin | 38 Test sites on skin |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Test sites on skin | 2 Test sites on skin | 2 Test sites on skin | 0 Test sites on skin |
| Race/Ethnicity, Customized Asian | 138 Test sites on skin | 61 Test sites on skin | 64 Test sites on skin | 13 Test sites on skin |
| Race/Ethnicity, Customized Black or African American | 44 Test sites on skin | 18 Test sites on skin | 21 Test sites on skin | 5 Test sites on skin |
| Race/Ethnicity, Customized Native Hawaiian | 4 Test sites on skin | 1 Test sites on skin | 2 Test sites on skin | 1 Test sites on skin |
| Race/Ethnicity, Customized Other | 8 Test sites on skin | 4 Test sites on skin | 3 Test sites on skin | 1 Test sites on skin |
| Race/Ethnicity, Customized White | 110 Test sites on skin | 49 Test sites on skin | 43 Test sites on skin | 18 Test sites on skin |
| Region of Enrollment United States | 308 Test sites on skin | 135 Test sites on skin | 135 Test sites on skin | 38 Test sites on skin |
| Sex/Gender, Customized Female | 140 Test sites on skin | 62 Test sites on skin | 62 Test sites on skin | 16 Test sites on skin |
| Sex/Gender, Customized Male | 168 Test sites on skin | 73 Test sites on skin | 73 Test sites on skin | 22 Test sites on skin |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 135 | 0 / 135 | 0 / 38 |
| other Total, other adverse events | 0 / 135 | 0 / 135 | 0 / 38 |
| serious Total, serious adverse events | 0 / 135 | 0 / 135 | 0 / 38 |
Outcome results
Primary
Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes
Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora
Time frame: 10 minutes
Population: The primary analysis data set used a modified intent-to-treat population. Subjects were excluded who did not meet the treatment day baseline requirements of 5.00 log10/cm\^2 on the inguinal test site. The number treatment arm-specific test sites is equal to the number of participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHG/IPA Surgical Skin Preparation | Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | 3.60 Log10 CFU/cm^2 | Standard Deviation 0.816 |
| CHG/IPA Film-Forming Surgical Skin Preparation: | Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | 3.61 Log10 CFU/cm^2 | Standard Deviation 0.837 |
| Normal Saline | Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | 1.15 Log10 CFU/cm^2 | Standard Deviation 0.411 |
Primary
Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours
Persistent efficacy endpoint which is a binary endpoint with success/failure, where success is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora
Time frame: 6 hours
Population: The primary analysis data set used a modified intent-to-treat population. Subjects were excluded who did not meet the treatment day baseline requirements of 5.00 log10/cm\^2 on the inguinal test site. The number treatment arm-specific test sites is equal to the number of participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHG/IPA Surgical Skin Preparation | Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | 1.98 Log10 CFU/cm^2 | Standard Deviation 0.806 |
| CHG/IPA Film-Forming Surgical Skin Preparation: | Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | 2.40 Log10 CFU/cm^2 | Standard Deviation 0.792 |
| Normal Saline | Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | 1.03 Log10 CFU/cm^2 | Standard Deviation 0.443 |