Status:
COMPLETED
Test for Pre Operative Skin Preparations
Lead Sponsor:
C. R. Bard
Conditions:
Topical Antisepsis
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (...
Detailed Description
Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applie...
Eligibility Criteria
Inclusion
- Subjects must read and sign an Informed Consent Form and be cooperative.
- Subjects must be in good general health.
- Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.
Exclusion
- Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis.
- A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system.
- Any medical condition that in the opinion of the investigator would preclude participation.
- Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling.
- Used UV tanning lamps 2 weeks prior to any microbial sampling.
- Bathing or showering less than 48 hours prior to any microbial sampling.
- Known sensitivity to chlorhexidine gluconate.
- Known sensitivity to latex (rubber).
- Known sensitivity to fragrances.
- Pregnant or nursing.
- Unwillingness to fulfill the performance requirements of the study.
- Subjects who have completed part or all of the study will not be reentered in the study.
Key Trial Info
Start Date :
November 13 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2008
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT00799812
Start Date
November 13 2007
End Date
June 19 2008
Last Update
December 11 2025
Active Locations (1)
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1
Microbiotest
Sterling, Virginia, United States, 20164