Surgical Scrub

Surgical Scrub

Surgical scrub formulations are designed to remove both the transient microorganism population as well as a large proportion of the normal endogenous microorganism population residing on the hands. In order to be considered effective, surgical scrub formulations must demonstrate both immediate and persistent antimicrobial effectiveness (up to six hours post scrub), and optimally demonstrate a "residual effect" by becoming more effective antimicrobially with repeated use over time due to the active ingredients being absorbed directly into the skin. 

BioScience Laboratories, Inc., (BSLI) has vast experience conducting surgical scrub's for both screening and submission purposes. BioScience Laboratories performs surgical scrub studies per the Tentative Final Monograph (TFM), pp. 31445-31448. The Cylinder Sampling Method is used for these studies and typically involve 30 subjects. 

BioScience Laboratories often will design relatively inexpensive pilot studies of surgical scrub products that use fewer subjects per product and ease some of the other requirements mandated by the TFM. Data from these studies will not be submitted to the FDA, but will serve as the basis for designing the much more extensive clinical study to follow.
 

SUMMARY

The FDA is familiar with BSLI generated Protocols and Final Reports. The FDA has a process in place for formal evaluation of the results of these studies (TFM, pp. 31445-31448).  Formally, these involve 30 subjects per product tested, which, at a minimum, will be two – a test product and a reference product,  another product approved by the FDA for use as a pre-surgical hand cleanser.  The latter serves as a reference for demonstration of the internal validity of the study.  The FDA criteria for approval of surgical scrub preparations are:
 

DAY 1: A 1 Log10 reduction in population in the immediate sample

DAY 2: A 2  Log10  reduction in population in the immediate sample

DAY 5: A 3  Log10  reduction in population in the immediate sample

DAYS 1, 2, AND 5: The 3-hour and 6-hour post-application populations for samples remain at less than the baseline population.  
 

Of note, also, is that Standard Method E 1115, a similar, but not identical method for the surgical scrub testing, is available from ASTM.

Labs
Methods
Industries

Clinical Laboratory

Our start-to-finish solution for clinical trials begins with understanding our client’s end goals for the study and aiding them in the study design.  Throughout the project we remain in on-going contact with our sponsors to ensure that the project is managed with the best interest of the client in mind.  

Learn More

ASTM - E1115

Standard Test Method for Evaluation of Surgical Hand Scrub Formulations

The procedure in this test method should be used to evaluate the activity of the test formulation in reducing the bacterial population of the hands immediately after a single use and to determine persistent activity (inhibition of growth) after…

Learn More

Health Care Antiseptic

For over 25 years BioScience Laboratories has led the industry in Healthcare antimicrobial product testing. BSLI is a GLP, FDA and EPA audited and Contract Research Organization providing Phase I through IV clinical trials, as well as, in-vitro testing services. Put our extensive experience to work, we are eager to help.

Learn More

Household Products

BioScience Laboratories, Inc. has the capability to test a wide range of household, non-durable products. From disinfectants and sanitizers to antimicrobial coatings, let BSLI help you with your testing needs. Our vast experience also reaches into materials testing for tensile strength, shear strength, moisture vapor transmission rate, and peel adhesion.…

Learn More