Clinical Testing of Topical ANtiseptics

OVERVIEW OF ANTISEPSIS

Soaps, washes, and scrubs containing antiseptic or antibacterial agents are often used to reduce the number of potentially harmful microorganisms on the skin. Hand or skin antisepsis requires the use of an antiseptic hand wash, antiseptic hand rub, or another product containing an antiseptic agent such as a pre-operative skin scrub or surgical scrub. Washing hands with antibacterial soap and water is an example of antiseptic handwashing where the cleansing agents are rinsed off following use. Leave-on hand sanitizers are examples of antiseptic hand rubs. Currently, the FDA supports the CDC recommendation2 to use non-antibacterial soap and water washes or a hand sanitizer if water is not readily available.

Topical Antiseptic1

Over the years, many types of antiseptic agents have been used including alcohols, chlorhexidine, chlorine, chloroxylenol (PCMX), hexachlorophene, iodine, various quaternary ammonium compounds, and triclosan. Recently the FDA began to review the use of these agents for both consumer and healthcare applications to ensure that they are “generally recognized as safe and effective” (GRASE).3 As part of this initiative, the FDA has issued a final ruling that requires triclosan, triclocarban, and other antiseptic agents to be removed from consumer antibacterial hand soaps and body washes.4 Because the use settings, target populations, and infection risks are different, Consumer Antiseptics and Healthcare Antiseptics are being assessed separately.


Standardized methods have been outlined for the evaluation of the efficacy of healthcare handwashes, surgical hand scrubs and other skin antisepsis products. As outlined by the CDC5, the methods used depend on the specific product protocols. Variables include the use and type of a pre-contamination step, the volume of product applied to the hands, the product contact time, the method for recovering bacteria from the skin, and how the product efficacy is reported. Most studies involve either removing transient flora (which may be artificially increased prior to evaluation) or removing resident flora (which typically is not artificially increased) from the skin. The use of a pre-contamination step often depends on the product use – for example preoperative scrub products are typically tested for their ability to remove resident flora without artificially contaminating the volunteers' hands prior to testing.

WHAT TESTING IS AVAILABLE?

Vivo Clinical Testing specializes in the clinical testing of topical antiseptic products in order to confirm the antimicrobial efficacy of the product. Our services Include:

  • Consumer Antiseptic Testing
    • Antimicrobial Hand Washes/Antimicrobial Soaps
    • Antimicrobial Hand Rubs/Hand Sanitizers
  • Healthcare Antiseptic Testing
    • Antimicrobial Hand Washes/Antimicrobial Soaps
    • Antimicrobial Hand Rubs/Hand Sanitizers
    • Pre-Operative Skin Scrub/Surgical Site Preparation Scrub Testing
    • Surgical Scrub Testing

why vIVO cLINICAL tESTING?

Vivo Clinical Testing is a contract testing laboratory designed to support the hand hygiene and infection control industry. Vivo Clinical Testing was founded in 2017 by Dr. Benjamin Tanner, a respected microbiologist and owner of Microchem Laboratory.  The Vivo Clinical Testing laboratory offers testing in compliance with current FDA, Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) regulations.  Clients are welcome to tour the lab, observe studies, and audit the lab's quality system. The lab is staffed by a capable, friendly group of scientists, mostly microbiologists.  We understand what our clients need:  Fairly priced testing services, done accurately and reported quickly. 

references:

  1. Photo credit to KMOV as published Sept. 05, 2016. http://www.kmov.com/story/33017567/fda-bans-antiseptic-chemicals-from-soaps-no-proof-they-work

  2. Handwashing: Clean Hands Save Lives. When & How to Wash your Hands http://www.cdc.gov/handwashing

  3. Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm444681.htm

  4. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use 09/06/2016. https://federalregister.gov/a/2016-21337

  5. Guideline for Hand Hygiene in Health-care settings https://www.cdc.gov/mmwr/Preview/Mmwrhtml/rr5116a1.htm