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MERLINTM One Step Prep Applicator Kit #605039 Antimicrobial Safety & Efficacy Study ("In Vivo Study")

Introduction:

An independent study, conducted by Microbiotest, Inc in Sterling, VA evaluated the safety and efficacy of the MERLINTM One Step Prep Applicator's combination antiseptic according to the FDA's Tentative Final Monograph for Health-Care Antiseptic Drug Products as a Patient Preoperative Skin Preparation (PPSP) containing a combination antiseptic of 72% IPA v/v and 7.5% (0.75% available Iodine) Povidone Iodine w/w. The MERLINTM applicator contains ExcelAP®*antiseptic, which is an Iodophor manufactured by Aplicare Inc. Meriden, CT.

Method:

The MERLINTM One Step Prep Applicator was evaluated per the FDA TFM** in-vivo test protocol, which is a modification of ASTM 1173 (Standard Test Method for the Evaluation of a Patient Preoperative Skin Preparation). Hibiclens®* Patient Preoperative Skin Preparation (2.0% CHG, aqueous) was also evaluated according to the protocol as a positive control. A total of 40 data points were collected for each product (N=40). Subjects were initially screened to insure that a minimum baseline bacterial load of 1.0 x 105 colony forming units (CFU)/cm2 in the inguinal (wet) site and 1.0 x 103 CFU/cm2 in the abdominal (dry) site were achieved. The MERLINTM One Step Prep Applicator was applied for 2 minutes, whereas the Hibiclens®* skin preparation positive control was applied for 4 minutes per the manufacturer's instructions. At 10 minutes, 6 hours, and 24 hours post application, samples were obtained to establish the remaining CFU population for both products. The FDA TFM** requires a 3.0 log10 reduction in CFU/cm2 of skin on inguinal sites and a 2.0 log10 reduction in CFU/cm2 of skin on abdominal sites within 10 minutes after antiseptic application. Also, the count must not exceed the baseline for a period of six hours post application.

Results:

The MERLINTM One Step Prep Applicator exceeded the FDA's TFM** requirements for patient preoperative skin prep. The table below depicts the number of CFUs for the abdominal and inguinal test sites. For more information on the safety and efficacy of the MERLINTM One Step Prep Applicator, visit www.abetterwaytoprep.com.

Table 1: Average Log10 Reduction, Using a 2-Minute Application Location 10 minutes 6 hours 24 hours Inguinal Site Abdominal Site 3.15 2.75 2.64 2.23 2.71 2.31

Graph of Antimicrobial Activity of MERLINTM Applicator on Normal Human Skin

Antimicrobial Activity on Human Inguinal Site

0

0

Antimicrobial Activity on Human Abdominal Site

Log Reduction

-1

Log Reduction

-1 -2 -3 -4

-2

-3

-4

10 Min

6 Hrs

24 Hrs

10 Min

6 Hrs

24 Hrs

Conclusion:

The MERLINTM One Step Prep Applicator exceeds the FDA TFM** requirements by demonstrating a 2.75 log10 reduction in the abdominal site and a 3.15 log10 reduction in the inguinal site 10 minutes post application and maintained the required CFU reduction below baseline for 6 hours . Additionally, the MERLINTM One Step Prep Applicator maintains approximately a 2- log10 reduction in the abdominal region and 3- log10 reduction in the inguinal region for 24 hours.

**Tentative Final Monograph for Health-Care Antiseptic Drug Products, Proposed Rule, June 17, 1994, (59 Fed. Reg. 31402) ®*ExcelAP is a U.S. registered trademark of Aplicare, Inc.; Hibiclens is a U.S. registered trademark of Regent Medical LTD. Copyright 2006, Tyco Healthcare Group LP. All rights reserved. TM Trademark of Tyco Healthcare Group LP or its affiliate

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Microsoft Word - Efficacy TFM White Paper NO HIBICLENS rev 082807.doc