DETERMINATION OF THE ANTIMICROBIAL EFFICACY OF TEST PRODUCTS USING THE HEALTH CARE PERSONNEL HANDWASH PROCEDURE

Phase 3

• Registration Number: CTRI/2011/091/000127
• Lead Sponsor: GOJO Industries Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 1000

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ILTimepoint: NI