Test for Pre Operative Skin Preparations
Condition: Topical Antisepsis
Intervention: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).; CHG 2% w/v & IPA 70% v/v swab applied sequentially; Aqueous CHG 4% w/v applied according to mfr's directions; Sterile swabstick with sterile water (3 @ once); Sterile swabstick with sterile water (one-at-a-time)
Intervention description: 3 swabsticks topically applied at the same time to intact skin; Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.; Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.; 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.; Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.
Intervention MeSH terms: Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 335.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: antimicrobial; antisepsis

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.
    

Eligibility criteria:

        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.