Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation
Condition: Preoperative Skin Preparation
Intervention: OCT - clear; OCT- tinted; ChloraPrep; Saline
Intervention description: Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear; Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted; Active Control: ChloraPrep® - Hi-Lite Orange® applicator; Negative Control: sterile 0.9% saline applied with single use applicator
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Objective of this study is to compare the antimicrobial properties of an investigational
      agent to an active control and a negative control when applied to specific body locations.
      Testing will be performed according to the procedures outlined in the Food and Drug
      Administration Tentative Final Monograph (TFM) for Effectiveness Testing of a Patient
      Preoperative Skin Preparation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects may be of either sex, at least 18 years of age and of any race.

          -  Subjects must be in good general health.

          -  Subjects must read and sign an Informed Consent Form, Authorization to Use and
             Disclose Protected Health Information Form, and the List of Restricted Products prior
             to participating in the study.

          -  Female subjects must complete a urine pregnancy test and have negative results
             documented before proceeding to treatment with test materials.

          -  All subjects must meet Screening Day microbial baseline requirements established by
             the sponsor.

        Exclusion Criteria:

          -  Known allergies or sensitivities to sunscreens, deodorants, laundry detergents,
             fragrances, vinyl, latex (rubber), alcohols, soaps, metals, inks, dyes, tape
             adhesives, or to common antibacterial agents found in soaps, lotions, ointments, or
             particularly the active ingredients of the study product drug solutions.

          -  Exposure of test sites to strong detergents, solvents, or other irritants within the
             14-day product-restriction period or during the test period.

          -  Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos,
             or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds,
             or sunbathing during the 14-day product-restriction period or during the test period.

          -  Wear fabric softener-, bug repellent-, or UV-treated clothing during the 14-day
             product-restriction period or during the test period.

          -  Use of systemic or topical antibiotic medications, steroid medications (other than for
             hormonal contraception or post-menopausal reasons), or any other product known to
             affect the normal microbial flora of the skin during the 14-day product-restriction
             period or during the test period.

          -  A medical diagnosis of a physical condition, such as a current or recent severe
             illness, mitral valve prolapse with a heart murmur, congenital heart disease,
             hepatitis B, hepatitis C, an organ transplant, ports, or an immunocompromised
             condition such as AIDS (or HIV positive), lupus, medicated diabetes (Type 1 or 2),
             ulcerative colitis, Crohn's disease, asthma requiring daily medication, fibromyalgia
             or multiple sclerosis (medicated).

          -  Any tattoos or scars 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, eczema) anywhere on the body that, in the opinion of the
             Principal Investigator, would compromise subject safety or study integrity.

          -  Subjects who receive an irritation score of 1 (any redness, swelling, rash, or dryness
             present in any treatment area) for any individual skin condition prior to the
             Screening Day baseline or Treatment Day baseline sample collection.

          -  Participation in another clinical study in the past 30 days or current participation
             in another clinical study at time of signing informed consent.

          -  Showering, bathing, or swimming within the 72 hour period prior to sampling for
             baseline screening, the test day, or throughout the test period.

          -  Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test
             and test periods of the study, or nursing a child. All female subjects will be
             required to complete a urine pregnancy test on the day of test material application,
             prior to treatment. Both gender of subjects must be willing to use an acceptable
             method of contraception to prevent pregnancy for at least 14 days immediately
             preceding Treatment Day and throughout the duration of the study.

          -  Any medical condition or use of any medications that, in the opinion of the Principal
             Investigator or Consulting Physician, would preclude participation.

          -  Unwillingness to fulfill the performance requirements of the study.