Test for Pre Operative Skin Preparations (NCT00799812) | Clinical Trial Compass
CompletedPhase 3
Test for Pre Operative Skin Preparations
United States335 participantsStarted 2007-11-13
Plain-language 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 (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
Timeframe: 10 minutes and 6 hours after application of test solutions