Surgical Skin Preparation
Conditions
Brief summary
The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.
Detailed description
The purpose of this study is to evaluate the antimicrobial properties of one finished test product (ZP) with a positive control (CP) and a negative control (ZP™ Vehicle without IPA) when used as a patient preoperative skin preparation.
Interventions
Sponsors
Zurex Pharma, Inc.
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 abdomen and groin * Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.
Exclusion criteria
* Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics. * Subjects with a history of skin sensitivity, skin allergies, or skin cancer. * Subjects who are pregnant, attempting pregnancy or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Reduction | 10 minutes post product application | A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success. |
| Bacterial Reduction - Abdomen | 10 minutes post product application | A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success. |
Countries
United States
Participant flow
Pre-assignment details
Enrollment consists of subjects that advanced from screening to randomization and treatment. Each subject had 2 test products applied bilaterally; therefore, the numbers will not add up uniformly across arms due to the pre-determined cohort/block design. Result totals will be less than than the treated number as the per subject/area/intervention anatomical site must have an acceptable baseline count/flora.
Participants by arm
| Arm | Count |
|---|---|
| Treated Population Each subject could have received 2 out of 3 test products randomly assigned. Demographics were not stratified by test product due to study design. While 440 was the treated population, to be evaluable for efficacy, each subject anatomical sample site (4/per subject) would need to pass the minimum log10 baseline requirements. | 440 |
| Total | 440 |
Baseline characteristics
| Characteristic | Treated Population |
|---|---|
| Age, Continuous | 38.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 379 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 119 Participants |
| Race (NIH/OMB) Black or African American | 84 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 61 Participants |
| Race (NIH/OMB) White | 176 Participants |
| Sex: Female, Male Female | 190 Participants |
| Sex: Female, Male Male | 250 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 400 | 0 / 400 | 0 / 80 |
| other Total, other adverse events | 0 / 400 | 0 / 400 | 0 / 80 |
| serious Total, serious adverse events | 0 / 400 | 0 / 400 | 0 / 80 |
Outcome results
Primary
Bacterial Reduction
A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.
Time frame: 10 minutes post product application
Population: Treated subjects with a treatment day baseline criteria of 5.0-7.5 log10 CFU/cm\^2 recoveries for each sampling site (2 groin sampling sites per subject).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mean Log Reduction - ZP (70% IPA) - Groin | Bacterial Reduction | 4.83 log10 CFU/cm^2 | Standard Deviation 0.1 |
| Mean Log Reduction - ChloraPrep - Groin | Bacterial Reduction | 4.78 log10 CFU/cm^2 | Standard Deviation 0.1 |
| Mean Log Reduction - ZP Vehicle - Groin | Bacterial Reduction | 2.23 log10 CFU/cm^2 | Standard Deviation 0.2 |
Comparison: Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.95% CI: [-0.188, 0.083]
Comparison: Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.95% CI: [2.396, 2.858]
Primary
Bacterial Reduction - Abdomen
A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success.
Time frame: 10 minutes post product application
Population: Treated subjects with a treatment day baseline criteria of 3.0 - 5.5 Log10 CFU/cm\^2 recoveries.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mean Log Reduction - ZP (70% IPA) - Groin | Bacterial Reduction - Abdomen | 3.35 Log10 CFU/cm^2 | Standard Deviation 0.1 |
| Mean Log Reduction - ChloraPrep - Groin | Bacterial Reduction - Abdomen | 3.34 Log10 CFU/cm^2 | Standard Deviation 0.1 |
| Mean Log Reduction - ZP Vehicle - Groin | Bacterial Reduction - Abdomen | 1.47 Log10 CFU/cm^2 | Standard Deviation 0.2 |
Comparison: Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.95% CI: [-0.102, 0.065]
Comparison: Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.95% CI: [1.766, 2.053]