Surgical Skin Preparation
Conditions
Brief summary
The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.
Detailed description
The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post-prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 0.5 log10 CFU/cm2.
Interventions
DRUGZuraPrep Clear Solution
Apply topically.
DRUGChloraPrep
Apply topically.
DRUGZuraPrep Vehicle
Apply topically.
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 general health * Minimum bacterial 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. * Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment. * Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate. * 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 - Groin | 30 seconds post product application | A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success. |
| Bacterial Reduction - Abdomen | 30 seconds post product application | A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region | 6 hours post product applcation | Bacterial counts should not exceed baseline on the abdomen or groin region |
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 |
|---|---|
| Treatment 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 156 was the treated population, to be evaluable for efficacy, each subject anatomical sample site (4/per subject) would need to pass the minimum log10 CFU/cm2 baseline requirements. | 156 |
| Treatment 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 156 was the treated population, to be evaluable for efficacy, each subject anatomical sample site (4/per subject) would need to pass the minimum log10 CFU/cm2 baseline requirements. | 72 |
| Total | 228 |
Baseline characteristics
| Characteristic | Treatment Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 156 Participants |
| Age, Continuous | 37.90 years STANDARD_DEVIATION 14.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 39 Participants |
| Race (NIH/OMB) Asian | 59 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 17 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 156 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 156 | 0 / 156 | 0 / 156 |
| other Total, other adverse events | 0 / 156 | 0 / 156 | 0 / 156 |
| serious Total, serious adverse events | 0 / 156 | 0 / 156 | 0 / 156 |
Outcome results
Primary
Bacterial Reduction - Abdomen
A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success.
Time frame: 30 seconds 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 | 3.036 Log10 CFU/cm^2 | Standard Deviation 0.4 |
| Mean Log Reduction - ChloraPrep - Groin | Bacterial Reduction - Abdomen | 3.087 Log10 CFU/cm^2 | Standard Deviation 0.4 |
| Mean Log Reduction - ZP Vehicle - Groin | Bacterial Reduction - Abdomen | 1.234 Log10 CFU/cm^2 | Standard Deviation 0.5 |
Comparison: Abdomen 30 seconds post product application, 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: [-0.1457, 0.2611]
Comparison: Abdomen 30 seconds post product application, 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: [1.6153, 2.0264]
Primary
Bacterial Reduction - Groin
A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.
Time frame: 30 seconds 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 - Groin | 4.133 log 10 CFU/cm2 | Standard Deviation 0.4 |
| Mean Log Reduction - ChloraPrep - Groin | Bacterial Reduction - Groin | 3.642 log 10 CFU/cm2 | Standard Deviation 0.5 |
| Mean Log Reduction - ZP Vehicle - Groin | Bacterial Reduction - Groin | 1.277 log 10 CFU/cm2 | Standard Deviation 0.6 |
Comparison: Groin 30 seconds post product application, 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: [-0.6033, 0.0334]
Comparison: Groin 30 seconds post product application, 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: [2.5415, 3.1655]
Secondary
Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region
Bacterial counts should not exceed baseline on the abdomen or groin region
Time frame: 6 hours post product applcation
Population: Subjects were treated and post treatment the 6 hour log10 CFU/cm2 values were evaluated for persistence. If the 6 hour value was below the baseline log10CFU/cm2 value, then the site had a persistent effect. This was calculated as a binary variable: 1 if the site had a persistent effect; 0 if not.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mean Log Reduction - ZP (70% IPA) - Groin | Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region | 72 Abd or groin with persistent effect |