A Phase 3 interventional study of ZuraPrep Clear Solution and ChloraPrep in Surgical Skin Preparation, sponsored by Zurex Pharma, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Zurex Pharma, Inc. · Phase 3, Interventional, and Prevention
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.
Zurex Pharma, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Isopropyl alcohol (IPA) 70%
Drug: ZuraPrep Clear Solution
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Drug: ChloraPrep
Zurex Prep without IPA
Drug: ZuraPrep Vehicle
Apply topically.
Also known as: Isopropyl alcohol 70%, ZP
Apply topically.
Also known as: CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Apply topically.
Also known as: Vehicle
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
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
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
| Milestone | All Study Participants |
|---|---|
| Started | 156 |
| Zp | 156 |
| Cp | 156 |
| Vehicle | 156 |
| Completed | 156 |
| Not completed | 0 |
A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.
| log 10 CFU/cm2 | Mean Log Reduction - ZP (70% IPA) - Groin | Mean Log Reduction - ChloraPrep - Groin | Mean Log Reduction - ZP Vehicle - Groin |
|---|---|---|---|
| Bacterial Reduction - Groin | 4.133 ± 0.4 | 3.642 ± 0.5 | 1.277 ± 0.6 |
A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success.
| Log10 CFU/cm^2 | Mean Log Reduction - ZP (70% IPA) - Abdomen | Mean Log Reduction - ChloraPrep - Abdomen | Mean Log Reduction - ZP Vehicle - Abdomen |
|---|---|---|---|
| Bacterial Reduction - Abdomen | 3.036 ± 0.4 | 3.087 ± 0.4 | 1.234 ± 0.5 |
Bacterial counts should not exceed baseline on the abdomen or groin region
| Abd or groin with persistent effect | ZP (70% IPA) |
|---|---|
| Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region | 72 |
Collected over 6 hours post product application. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zurex Prep (70% IPA) | 0/156 (0%) | 0/156 (0%) | 0/156 (0%) |
| ChloraPrep | 0/156 (0%) | 0/156 (0%) | 0/156 (0%) |
| Zurex Prep Vehicle | 0/156 (0%) | 0/156 (0%) | 0/156 (0%) |
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.
| Age, Categorical(Participants) | Treatment Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 156 |
| >=65 years | 0 |
| Age, Continuous(years) | Treatment Population |
|---|---|
| Mean | 37.90 ± 14.93 |
| Sex: Female, Male(Participants) | Treatment Population |
|---|---|
| Female | 60 |
| Male | 96 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Population |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 150 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment Population |
|---|---|
| American Indian or Alaska Native | 39 |
| Asian | 59 |
| Native Hawaiian or Other Pacific Islander | 17 |
| Black or African American | 0 |
| White | 41 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment Population |
|---|---|
| United States | 156 |
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Plan to share: No
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Zurex Pharma, Inc.