None listed
Conditions
Interventions
Intervention1: PURELL Original, Green PURELL, PURELL 70, PURELL 70 HE Gel, PURELL 70 HE Foam, PURELL Skin Nourishing Foam, BAK HIS prototype, MICRELL Foam, PURELL Foam, Woodwards Handclens, PURELL VF4
G Antibacterial Safeguard liquid bulk soap, EcoLab DigiClean Antibacterial Foam Handwash, Kay Fortress Antibacterial Foam Handwash, DEB Antibacterial Foam Handwash, DCT instant hand sanitizer gel, Eco
Sponsors
GOJO Industries Inc
Jehangir Clinical Development Centre
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers may be of either sex, at least eighteen, but not more than seventy years of age, and of any race. Volunteers must possess both hands. Volunteers must be free of dermatoses, cuts, lesions, hangnails, or other skin disorders on the hands and forearms. Volunteers must not have used topical or systemic antimicrobials, antibiotics, or steroids for the one week pre-test conditioning period and must agree to abstain from these materials until the completion of the study. Volunteers must be in good general health. Volunteers must have read and signed an Informed Consent Form, and List of Restricted Products.
Exclusion criteria
Exclusion criteria: Exposure of ungloved hands and forearms to antimicrobial agents, medicated soaps, medicated shampoos, hair mousses, or medicated lotions, or use of biocide-treated pools or hot tubs during the seven day pre-test conditioning period or on the single test day. Exposure of ungloved hands or forearms to strong detergents, solvents, or other irritants during the seven day pre-test conditioning period or on the single test day. Use of systemic or topical antibiotic medications during the seven day pre-test conditioning period or on the single test day. Known allergies to latex (rubber), alcohol, or to common antibacterial agents found in soaps, lotions, or in ointments, particularly ethanol or chlorhexidine gluconate, or topical antibiotic ointments (e.g., Neosporin® [neomycin/bacitracin/polymyxin B]). Knowledge of diagnosis of a physical condition, such as asthma, diabetes, hepatitis, an organ transplant, AIDS (or HIV positive), any immunocompromising disease, mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures (verbal confirmation is acceptable) Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child. Any active skin rashes or breaks in the skin of hands or forearms. A currently active skin disease or inflammatory skin condition, including contact dermatitis. Participation in a clinical study in the past thirty days or current participation in another clinical study. Any medical condition or use of any medications that, in the opinion of the Investigator, should preclude participation. Unwillingness to fulfill the performance requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the antimicrobial effectiveness of various test products for use as Health Care Personnel Handwashes using indicator microorganism Serratia marcescens for hand contaminations. Between 8 to 24 volunteers is tested using each test configuration over eleven consecutive hand contaminations, the first followed by baseline sample and the remaining ten by product applications, with microbial samples taken after product applications one, three, seven, and ten.Timepoint: Critical indices are a two log10 reduction at wash 1 and a three log10 reduction at wash 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Vikram Padbidri
Consultant Microbiologist
Outcome results
None listed