Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth
Condition: Preoperative Skin Preparation
Intervention: Octenidine Dihydrocloride in aqueous solution; Vehicle Control; Saline Control
Intervention description: application of investigational product; application of vehicle control; application of placebo
Intervention MeSH terms: Octenidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Healthy volunteers will receive treatment to two body locations with the investigational
      product and placebo and the antimicrobial effectiveness of each treatment will be measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and/or females, at least 18 years or older and of any race.

          -  Are in good general health.

          -  Unable to become pregnant, or willing to use an acceptable method of contraception
             (i.e. oral contraception, intra-uterine device [IUD], diaphragm, condom, abstinence,
             bilateral Tubal ligation, or are in a monogamous relationship with a partner who has
             had a Vasectomy) to prevent pregnancy for at least 14 days immediately preceding
             Treatment Day and throughout the duration of the study, if female of child-bearing
             potential.

          -  All female subjects must have a negative urine pregnancy test on Treatment Day prior
             to any applications of the study products.

          -  Have skin within 6 inches of the test sites that is free of dermatoses, abrasions,
             cuts, lesions or other skin disorders.

          -  Cooperative and willing to follow Subject Instructions

          -  Cooperative and willing to sign Consent Form and HIPAA Authorization Form.

          -  Able to read, write and follow instructions in English.

        Exclusion Criteria:

          -  Exposure to topical or systemic antimicrobials or any other product known to affect
             the normal microbial flora of the skin, antibiotics or steroids (other than hormones
             for contraception or post-menopausal reasons) exposure within 14 days prior to
             Treatment Day and for the remainder of the study. Restrictions include, but are not
             limited to antimicrobial-containing soaps, antiperspirants/deodorants, shampoos,
             lotions, perfumes, after shaves, and colognes.

          -  Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools
             within 14 days prior to Treatment Day and for the remainder of the study.

          -  Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable
             test areas) within 14 days prior to Treatment Day and for the remainder of the study.

          -  Contact with strong detergents, solvents, acids, bases, bug repellant, fabric
             softener-treated clothing, UV treated clothing or other household chemicals in the
             applicable test areas within 14 days of the Treatment Day and for the remainder of the
             study.

          -  Subjects who have a history of sensitivity to vinyl, natural rubber latex, adhesive
             skin products (e.g., Band-Aids, medical tapes), polyester, metals, inks, common
             antibacterial agents found in common personal beauty or personal care soaps, lotions,
             or ointments

          -  Subjects who have asthma requiring medication, diabetes, hepatitis B or C, an organ
             transplant, mitral valve prolapse with a heart murmur, congenital heart disease,
             lupus, Crohn's disease, medicated multiple sclerosis, internal prosthesis or any
             immunocompromised conditions (such as AIDS or HIV positive).

          -  Subjects who have a history of skin allergies.

          -  Subjects who have a history of skin cancer within 6 inches of the applicable test
             areas or have received treatment for any type of internal cancer within the 5 years
             prior to enrollment.

          -  Any tattoos or scars on the test sites or within 2 inches of the test sites; skin
             blemishes or warts may be permissible with the specific approval of the Principal
             Investigator or consulting physician.

          -  Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin
             disorders within 6 inches on or around the test sites.

          -  A currently active skin disease or inflammatory skin condition (for example contact
             dermatitis; psoriasis, and eczema) anywhere on the body.

          -  Subjects who are pregnant, attempting pregnancy, or nursing.

          -  Subjects who have showered or bathed within at least 72 hours of the Treatment Day
             (sponge baths may be taken, however, the lower abdomen and upper thigh region must be
             avoided).

          -  Subjects who receive an irritation score of 1 (any redness, swelling, rash, or dryness
             present at any treatment area) for any individual skin condition prior to the
             Treatment Day baseline sample collection.

          -  Participation in another clinical trial in the 30 days prior to signing the informed
             consent for this study, current enrollment in another clinical trial, or have already
             participated in this study.