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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZP (70% IPA) | Experimental | Isopropyl alcohol (IPA) 70% |
|
| ChloraPrep | Active Comparator | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% |
|
| ZP Vehicle | Placebo Comparator | ZP without IPA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZuraPrep | Drug | Apply topically. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Reduction | A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success. | 10 minutes post product application |
| Bacterial Reduction - Abdomen | A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success. | 10 minutes post product application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad H Bashir | Microbac Laboratories, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MicroBioTest Laboratories | Sterling | Virginia | 20164 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32131912 | Derived | Edmiston CE, Lavin P, Spencer M, Borlaug G, Seabrook GR, Leaper D. Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis. Infect Control Hosp Epidemiol. 2020 Jun;41(6):653-659. doi: 10.1017/ice.2020.27. |
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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 Participants | ZP (Isopropyl alcohol (IPA) 70%) or CP or ZP Vehicle Applied topically to ab (for 30 seconds) or groin (for 2 minutes). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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 | log10 CFU/cm^2 | 10 minutes post product application |
|
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 | ZP (70% IPA) | Isopropyl alcohol (IPA) 70% ZP: Apply topically. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Morgan | Zurex Pharma, Inc. | 16082039090 | amorgan@zurexpharma.com |
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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 | Jul 11, 2016 | Jun 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C547847 | citrate, isopropyl alcohol, methylene blue, parabens drug combination |
| D000431 | Ethanol |
| D002864 | Chromogranins |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| ChloraPrep | Drug | Apply topically. |
|
|
| ZP Vehicle | Drug | Apply topically. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Mean Log Reduction - ZP Vehicle - Groin | ZP without IPA ZP Vehicle: Apply topically. |
|
|
|
| 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 | 10 minutes post product application |
|
|
|
|
| 400 |
| 0 |
| 400 |
| 0 |
| 400 |
| EG001 | ChloraPrep | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% ChloraPrep: Apply topically. | 0 | 400 | 0 | 400 | 0 | 400 |
| EG002 | ZP Vehicle | ZP without IPA ZP Vehicle: Apply topically. | 0 | 80 | 0 | 80 | 0 | 80 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| 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. | Mean Difference (Final Values) | 1.909 | 2-Sided | 95 | 1.766 | 2.053 | Superiority | Investigational product lower bounds must be greater than 1.2. |