Status:
COMPLETED
In Vivo Efficacy Study of Patient Preoperative Preps
Lead Sponsor:
3M
Conditions:
Bacterial Reduction Post-product Application
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
Detailed Description
The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70% On the abdominal si...
Eligibility Criteria
Inclusion
- Subjects of any race
- Subjects in good health
- Minimum skin flora baseline requirements on abdomen and groin
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 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
738 Patients enrolled
Trial Details
Trial ID
NCT02203591
Start Date
July 1 2014
End Date
March 1 2015
Last Update
November 23 2020
Active Locations (1)
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1
BioScience Laboratories, Inc.
Bozeman, Montana, United States, 59718