TRUSTED • PROVEN
The global standard for bleeding control Over 100 million uses worldwide and over 50 years of experience 1,2,3
SURGICEL®
• Highest purity among 11 competitor products tested
— Demonstrated by lowest metals content4,6
• Highest carboxyl content demonstrates manufacturing quality6,7,14
• Broadest bactericidal properties against top 5 pathogens isolated from surgical site infections8,9
Absorbable Haemostats vs. competitor alternatives SURGICEL®
Heavy metal content4,5† Carboxyl content6,7,14‡ Bactericidal properties8,9§
Bioabsorption, in vitro10,II
Absorbable Haemostats 0.012%w/w 18%–21%w/w
Consistent efficacy against all 5 challenge bacteria
<24 h
Competitor Products*
0.014% - 6.87%w/w variable
Varying antibacterial activity against 5 bacterial strains
>24 h %w/w = percentage weight/weight.
References: 1. Data on file, Ethicon, Inc. Patient Data. 2. Hong Y, Loughlin K. The use of hemostatic agents and sealants in urology. J Urol. 2006;176:2367-2374. 3. Data on file, Ethicon, Inc. A compendium of scientific literature: evidence supporting the efficacy and safety of the SURGICEL®
family of absorbable hemostats. 4. Ethicon Applied Science and Technology Report No. CP505: Heavy metal analysis of oxidized regenerated cellulose products. G Chiang, 2012. 5. Ethicon Applied Science and Technology Report No. CP505 Addendum.
Heavy metal analysis of oxidized regenerated cellulose products. 6. Ethicon AST-2012-0396: Carboxyl content analysis on competitor TAH products by USP ORC Method, Q Min, September 2012. 7. RDCF#25/2-52849: Competitive assessments of hemostatic products. G Zhang, A Wang, September 2009. 8. Ethicon RDCF 25/2-52851: Competitive assessment of topical absorbable hemostats (TAH) for bactericidal activity. S Bhende, 2012. 9. Ethicon RDCF25/2-52852: Competitive assessment of topical absorbable hemostats (TAH) for bactericidal activity (Phase II), S Bhende, 2012. 10. RDCF Allen Wang: Phase I and II dissolution testing report—file in RDCF. 11. SURGICEL®
Absorbable Hemostat Full Prescribing Information. Ethicon, Inc. 12. USP 35, August 2012, pages 2582 to 2583. 13. Centers for
Disease Control and Prevention. National nosocomial infections surveillance (NNIS) system report, data summary from January 1992 through June 2004, issued October 2004. Am J Infect Control. 2004;32:470-485. 14. RDCF#25/2-52848: Examination of Gelitacel and Curacel as compared to SURGICEL Original, A Wang, G Zhang, May 2010 *Highlights USP standard for heavy metal content and carboxyl content parameters. † In a comparison of SURGICEL¨
Original Absorbable Haemostat with other ORC and OC topical haemostats, the elements included in the testing were USP Classes I and II heavy metals and some common elements (Na, Mg, Ca, Fe, Se, and Ba) that may derive from additives, processing, processing equipment, and processing aids. USP maximum is 0.15%.12
‡ Carboxyl content of 9 competing absorbable haemostats measured by USP for ORC method; USP recommends 18% to 24%w/w. § The top 5 pathogens as defined by the National Nosocomial Infections Surveillance System (NNISS): MRSA, MRSE, VRE, Escherichia coli, and P aeruginosa. Testing compared SURGICEL¨ The clinical significance of these animal or in vitro data has yet to be determined. Closing SURGICEL¨
|| Product samples were incubated in phosphate buffered solution (pH7.3) at 37°C at various time periods. The ratio of the sample to phosphate buffered solution: 5mg/mL. and 7 other topical absorbable haemostats in vitro.13 Absorbable Haemostat into a contaminated wound without drainage may lead to complications and should be avoided.
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