Status:
COMPLETED
Efficacy Study of Patient Preoperative Preps In-vivo
Lead Sponsor:
Solventum US LLC
Collaborating Sponsors:
3M
Conditions:
Surgical Skin Preparation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.
Detailed Description
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes...
Eligibility Criteria
Inclusion
- Subjects of any race
- Subjects in good health
- Minimum skin flora baseline requirements on inguinal region
Exclusion
- Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
- 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
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2021
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04756154
Start Date
July 6 2020
End Date
April 28 2021
Last Update
October 1 2024
Active Locations (1)
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1
Microbac Laboratories, Inc
Sterling, Virginia, United States, 20164