Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
154 participants
INTERVENTIONAL
2020-07-06
2021-04-28
Brief Summary
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Detailed Description
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Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used.
Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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CHG/IPA Surgical skin preparation
Apply topically to the inguinal region for 2 minutes
CHG/IPA Surgical skin preparation
Apply topically to the inguinal region for 2 minutes
CHG/IPA Film-Forming Surgical skin preparation
Apply topically to the inguinal region for 2 minutes
CHG/IPA Surgical skin preparation
Apply topically to the inguinal region for 2 minutes
Normal saline
Apply topically to the inguinal region for 2 minutes
Normal saline
Apply topically to the inguinal region for 2 minutes
Interventions
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CHG/IPA Surgical skin preparation
Apply topically to the inguinal region for 2 minutes
Normal saline
Apply topically to the inguinal region for 2 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects in good health
* Minimum skin flora baseline requirements on inguinal region
Exclusion Criteria
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
18 Years
ALL
Yes
Sponsors
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3M
INDUSTRY
Solventum US LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Muhammad H Bashir, MD, CCRP
Role: PRINCIPAL_INVESTIGATOR
Microbac
Locations
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Microbac Laboratories, Inc
Sterling, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Combined Protocol and Statistical Analysis Plan
Document Type: Statistical Analysis Plan: Detailed Statistical Analysis Plan
Other Identifiers
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EM-05-014624
Identifier Type: -
Identifier Source: org_study_id
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