Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation
Condition: Bacteria Microflora Reduction
Intervention: Project X 26ml; Project X 5.1ml; Prevantics Maxi Swabstick
Intervention description: Application of antiseptic drug to the inguinal and abdomen areas of the subjects; Application of antiseptic drug to the inguinal and abdomen areas of the subjects; Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Samples are blinded to the participant and technical team
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Comparative Study of Antimicrobial Effectiveness Evaluation of 26ml Project X, 5.1ml Project
      X and Prevantics Maxi Swabstick following ASTM E1173 - Standard Test Method for Evaluation of
      Preoperative, Precatheterization, or Preinjection Skin Preparations, ASTM International, West
      Conshohocken, Pennsylvania, 2015
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects may be of either sex, at least 18 years of age, and of any race.

          -  Subjects must be able to read and understand English.

          -  Subjects must have read and signed an Informed Consent Form, Authorization to Use and
             Disclose Protected Health Information Form, and List of Restricted Products prior to
             participating in the study, all located in the separate Informed Consent documents.

          -  Subjects must be in good general health and have no medical diagnosis of a physical
             condition, such as a current or recent severe illness, medicated or uncontrolled
             diabetes, hepatitis B, hepatitis C, an organ transplant, mitral valve prolapse with
             heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, an immunocompromised
             condition such as AIDS (or HIV positive), lupus, or medicated multiple sclerosis.

          -  Subjects will have test sites on the skin of the abdomen and/or inguinal free of
             injury and in good condition (no active skin rashes, excessive freckling, moles,
             scratches, breaks in the skin, etc.) and have no currently active skin diseases or
             skin conditions (for example, contact dermatitis, psoriasis or eczema) that may
             compromise subject safety or study integrity.

          -  Subjects must have skin within 6 inches of the test sites that is free of tattoos,
             dermatoses, abrasions, cuts, lesions or other skin disorders. Subjects with tattoos,
             scars, active skin rashes, or breaks in the skin of test sites, skin blemishes, such
             as dry scabs or warts, may be admitted at the discretion of the Principal
             Investigator, Subinvestigators, or Consulting Physicians.

        Exclusion Criteria:

          -  Known allergies to vinyl, latex (rubber), alcohols, metals, tapes or adhesives, inks,
             sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers,
             or to common antibacterial agents found in soaps or lotions, particularly
             chlorhexidine gluconate or ethanol.

          -  Have experienced hives (raised welts) as a reaction to anything that contacted the
             skin.

          -  Use of systemic or topical antibiotic medications during the 14-day pre-test period
             through completion of testing on the single test day.

          -  Use of systemic or topical steroids, other than for contraception, hormone therapy,
             post-menopausal indications, during the 14-day pre-test period through completion of
             testing on the single test day. This includes steroid medications used to treat
             asthma. Note: topically applied hormonal steroids used for post-menopausal reasons
             must not get on the test sites.

          -  Any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).

          -  Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test
             and test period of the study, or nursing a child. Female subjects must have a negative
             urine pregnancy test documented before treatment with test materials.

          -  Current participation or participation in a clinical study in the past 14 days.

          -  Any medical condition or use of any medications that, in the opinion of the Principal
             Investigator or consulting physicians, would preclude participation.