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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZuraPrep (70% IPA) | Experimental | Isopropyl alcohol (IPA) 70% |
|
| ChloraPrep | Active Comparator | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% |
|
| ZuraPrep Vehicle | Placebo Comparator | Zurex Prep without IPA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZuraPrep Clear Solution | Drug | Apply topically. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Reduction - Groin | A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success. | 30 seconds post product application |
| Bacterial Reduction - Abdomen | A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success. | 30 seconds post product application |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region | Bacterial counts should not exceed baseline on the abdomen or groin region | 6 hours post product applcation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M H Bashir, MD | Microbac Laboratories, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Microbac Laboratories, Inc. | Sterling | Virginia | 20164 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | ZP (Isopropyl alcohol (IPA) 70%) or CP or ZP Vehicle, applied topically to abdominal (for 30 seconds) or groin (for 2 minutes). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects must have the following bacteria counts to entry study, for the abdomen, the allowable baseline log10 CFU/cm2 value > 3.0; for the groin, the allowable baseline log10 CFU/cm2 value > 5.0.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacterial Reduction - Groin | A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success. | 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). | Posted | Mean | Standard Deviation | log 10 CFU/cm2 | 30 seconds post product application | Abdomen or groin | Abdomen or groin |
|
6 hours post product application
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zurex Prep (70% IPA) | Isopropyl alcohol (IPA) 70% ZuraGard Clear Solution: Apply topically. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Morgan Exec. VP RA/QA Clinical | Zurex Pharma | 16082175239 | amorgan1@charter.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2018 | May 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D002864 | Chromogranins |
| C010882 | chlorhexidine gluconate |
| C547847 | citrate, isopropyl alcohol, methylene blue, parabens drug combination |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| ChloraPrep | Drug | Apply topically. |
|
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| ZuraPrep Vehicle | Drug | Apply topically. |
|
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| Abdomen or groin |
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| Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| OG002 | Mean Log Reduction - ZP Vehicle - Groin | ZP without IPA ZP Vehicle: Apply topically. |
|
|
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| Primary | Bacterial Reduction - Abdomen | A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success. | Treated subjects with a treatment day baseline criteria of 3.0 - 5.5 Log10 CFU/cm^2 recoveries. | Posted | Mean | Standard Deviation | Log10 CFU/cm^2 | 30 seconds post product application | Abdomen or groin | Abdomen or groin |
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| Secondary | Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region | Bacterial counts should not exceed baseline on the abdomen or groin region | 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. | Posted | Number | Abd or groin with persistent effect | 6 hours post product applcation | Abdomen or groin | Abdomen or groin |
|
|
|
| 0 |
| 156 |
| 0 |
| 156 |
| 0 |
| 156 |
| EG001 | ChloraPrep | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% ChloraPrep: Apply topically. | 0 | 156 | 0 | 156 | 0 | 156 |
| EG002 | Zurex Prep Vehicle | Zurex Prep without IPA Zurex Prep Vehicle: Apply topically. | 0 | 156 | 0 | 156 | 0 | 156 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| 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. | Mean Difference (Final Values) | 1.8208 | 2-Sided | 95 | 1.6153 | 2.0264 | Superiority | Investigational product lower bounds must be greater than 1.2. |