Test for Pre Operative Skin Preparations
Completed · Phase 3
Conditions studied: Topical Antisepsis
In brief
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 (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.
Key facts
- Study ID
- NCT00799812
- Run by
- C. R. Bard
- People needed
- 335
- Starts
- 2007-11-13
- Expected to finish
- 2008-06-19
- Last updated by the study team
- 2025-12-11
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Microbiotest — Sterling, Virginia, United States
Full record on ClinicalTrials.gov
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