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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.
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.
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