Clinical trial: Evaluation of the Residual Antimicrobial Efficacy of One Test Material Based on a Modification of ASTM E1115-11 Test Method (NCT04654182)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects may be of either sex, between the ages of 18 and 65 years, and of any race.

          -  Subjects must be able to read and understand English.

          -  Subjects must possess both hands and all ten digits.

          -  Subjects must have an average baseline population of at least 1.0 x 105 colony forming
             units (CFU) per hand.

          -  Subjects must have no active skin rashes, dermatoses, hangnails, or breaks in the skin
             of the hands or forearms. Subjects must also have no inflammatory skin conditions,
             such as dermatitis, eczema, or psoriasis, anywhere on the body.

          -  Subjects must be in good general health and have no medical diagnosis of a physical
             condition, such as a current or recent severe illness, a heart murmur, mitral valve
             prolapse with heart murmur, congenital heart disease, an organ transplant, medicated
             or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition
             such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's
             disease, asthma, heart disease, hypertension, or medicated multiple sclerosis.

          -  Subjects must have read and signed the Informed Consent Form, List of Restricted
             Products, and Allowed and Restricted Products For Hand Cleaning During Coronavirus
             Disease 2019 (COVID-19) Pandemic prior to participating in the study, all located in
             the separate Informed Consent documents. Subjects must also have a current
             Authorization to Use and Disclose Protected Health Information Form on file at the
             testing facility.

        Exclusion Criteria:

          -  Have participated in a clinical study in the past 7 days or be currently participating
             in another clinical study.

          -  Wash the hands or applying lotion within the 2-hour period prior to baseline sampling
             or testing.

          -  Be experiencing any signs/symptoms of respiratory illness, including cough, fever
             (body temperature of ≥ 100.0 °F) or chills, shortness of breath or difficulty
             breathing, persistent pain or pressure in the chest, confusion or inability to respond
             to external stimuli, bluish lips/face, loss of taste/smell, sore throat, headache,
             nasal discharge ("runny nose"), frequent sneezing, or general fatigue / body aches.

          -  Have a current diagnosis of active Coronavirus Disease 2019 (COVID-19) or have been in
             close contact within the last 2 weeks of anyone who has been diagnosed as having
             contracted COVID-19.

          -  Have been regularly smoking or vaping over the past 2 years.

          -  Have limited mobility or dexterity that would hamper their ability to perform the
             study as directed.

          -  Have known allergies or sensitivities to latex (rubber), alcohols, sunscreens,
             deodorants, laundry detergents, topically applied fragrances, cleansers, soaps,
             lotions, or to common antibacterial agents, particularly chlorohexidine gluconate.

          -  Have experienced hives (raised welts) as a reaction to anything that contacted the
             skin with the exception of plants known to cause reactions for most humans (e.g.,
             poison oak or poison ivy).

          -  Have a history of anaphylactic shock, anaphylactoid reaction, or anaphylactoid shock.

          -  Have a known hypersensitivity to the test product or any of its components, especially
             in those with a history of possible chlorhexidine-related allergic reactions.

          -  Contact the brain, cerebral membrane, middle ear and eyes with the test product and
             such contact must be avoided.

          -  Be receiving any antibiotic medications during the 7-day pre-test period through
             completion of the study.

          -  Be receiving any steroids (including steroid medications used to treat asthma) other
             than for contraception, hormone therapy, or menopausal purposes during the 7-day
             pre-test period through completion of the study.

          -  Have any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).

          -  Be nursing a child.

          -  Be pregnant, plan to become pregnant or impregnate a sexual partner within the
             pre-test and test periods of the study.

          -  Have any medical condition or use any medications that, in the opinion of the
             Principal Investigator, or Consulting Physician(s) should preclude participation.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? 0