Initial results from Phase I Clinical Trials are now available. 

       The initial set of Phase I clinical trials data from forty healthy human volunteers was collected at the VA Medical Center in Tucson, AZ by a team of four researchers led by Dr. Ronald Schifman, MD. Current results support the principle of operation and indicate that Clean Collect may be capable of reducing contamination rates to as low as 0.625% from the current range of 2-6%. Phase I trials have been extended and increased by 300 human subjects in order to solidify the proof of principle. The extension is currently underway and complete results are expected in April 2009. Contact us to receive the full Phase I report.

In vitro studies demonstrate the efficacy of Venipuncture Contaminant Exclusion

     The efficacy of the blood collection method designated Venipuncture Contaminant Exclusion or VCE, has been supported by in vitro studies performed at the Stone Technologies Lab with measurements performed at Integrated DNA Technologies of Iowa City, IA. The experiment used a living model of venipuncture comprised of Meleagris gallopavo integument cultured in trypticase soy broth and a special container designed to hold the integument over a fluid reservoir. Fluid samples were then collected and 
cultured to determine the concentration of microorganisms in the fluid sample. Figure 1 below shows the summary results of five trials. The optical densities are indicative of microbial growth in the fluid samples. These results strongly suggest that the first fluid sample contains vastly more microbes from the skin than subsequently collected fluid samples. When combined with the use of topical antiseptics to treat the venipuncture site, sterile collection of an initial blood sample (VCE method) is predicted  to reduce blood culture contamination rates considerably. A complete copy of this study can be ordered by Contacting Us

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