Evaluation of the Residual Antimicrobial Efficacy of One Test Material Based on a Modification of ASTM E1115-11 Test Method

NCT04654182 | Completed Phase 4 FDA Drug

• 1 other identifier: #2007591-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the residual antimicrobial effectiveness of one test product when tested using a modification of the methodology of the standardized ASTM E115-11 (2017)

Conditions

Hand Hygiene

Outcome Measures

Primary Outcomes (2)

• Bacterial counts

  Average Log reduction in counts

  at 6 hours

• Bacterial Counts

  Average Log reduction in counts

  at 12 hours

Study Arms (1)

Log reduction in bacterial count

EXPERIMENTAL

Following pre-test period qualifying participants will wash their hands with 4% CHG product 3 times a day over the 5 day study period. Bacterial counts will be taken at 6 and 12 hours after the final wash on day 5 and reductions calculated from the starting count to final count.

Drug: Chlorhexidine Gluconate

Interventions

Chlorhexidine Gluconate DRUG

Product used in accordance with manufacturers Hand Hygiene instructions

Log reduction in bacterial count

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead
• BioScience Laboratories, Inc.: collaborator

Study Sites (1)

Bioscience Laboratories, Inc

Bozeman, Montana, 59718, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: November 30, 2020
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)