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Reference

1

Data on file, Medtrade.  In laboratory testing Celox was effective on heparinized blood, blood at 65 °F blood temperature and did not increase in temperature during use.  

2

Tan ECTH, Bleeker CP. Field experience with a chitosan-based hemostatic dressing. MCI Forum. 2011; 3/4-2011: 34-39.

3

Pozza M, Millner R.  Celox (chitosan) for hemostasis in massive traumatic bleeding: experience in Afghanistan. Eur J Emerg Med.  2011; 18: 31-33.

4

Observed in laboratory testing. Medtrade data on file.

5

Rall J et al. Comparison of novel hemostatic dressings with QuikClot combat gauze in a standardized swine model of uncontrolled haemorrhage. J Trauma. 2013; 75: S150 – S156

6

Littlejohn LF et al. Comparison of Celox-A, ChitoFlex, WoundStat and Combat Gauze hemostatic agents versus standard gauze dressing in control of hemorrhage in a swine model of penetrating trauma.  Acad Emer Med. 2011; 18: 340-350.

7

Kozen B et al. An Alternative Hemostatic  Dressing: Comparison of CELOX, HemCon and QuikClot.  Acad Emer Med.  2008; 15:74-81.

8

Product instructions for use.

9

Kunio N et al.  Chitosan based advanced hemostatic dressing is associated with decreased blood loss in swine uncontrolled hemorrhage model.  Am J Surg. 2013; 205:505-510.

10

Hoggarth A et al.  Mechanism of action of a rapid-acting gauze hemostat.  Poster presentation at ATACCC 2011, Fort Lauderdale, FL.

11

Nancy Caroline’s Emergency Care in the Streets. Nancy Caroline. Jones & Bartlett, Sudbury MA 2008.

12

DoD test results reference based on 10’ Celox™Gauze.

13

CDC/NCHS, Health United States 2013, Data from National Health and Nutritional Examination

Survey.

14

Contains chitosan from shellfish – allergy studies show no adverse reactions – data on file.

15

Johnson L et al. The in vivo assessment of an unusual new hemostat technology.”  Presented at SAWC, April 2008, San Diego.

16

Peng T. Biomaterials for hemorrhage control. Trends Biomat Artif Organs. 2010; 24(1): 27-68.

17

Millner R, Lockhart A. Omni-stat (chitosan) arrests bleeding in heparinised subjects in vivo: an experimental study in a model of major peripheral vascular injury.  Eur J Cardiothorac Surg 2011; 39(6): 952-954.

18

Waibel KH et al. Safety of chitosan bandages in shellfish allergic patients. Mil Med 2011; 176: 1153-6.

19

Baldrick P. The Safety of Chitosan as a pharmaceutical excipient. Regul Toxicol Pharmacol 2010; 56(3):290-9.

20

Scherle C, Krol J. Can new hemostatic dressings facilitate sharp debridement in high-risk patients? Podiatry Today 2009; 22(7):20-22.

21

Snyder RJ, Sigal BD. An open-label controlled clinical study of OMNI-STAT (Chitosan) versus standard of care in post-debridement treatment of patients with chronic wounds with or without concomitant use of anticoagulants.  Wound Care and Hyperbaric Medicine 2013; 4(2): 9-16.

22

Medtrade Data on File

23

Eastridge B et al. Death on the battlefield (2001Y2011): Implications for the future of combat casualty care. J Trauma 2012; 73(6): S431-S437.

24

Watters JM et al. Advanced hemostatic dressings are not superior to gauze for care under fire scenarios. J Trauma 2011;70:1413-1419.

25

https://archive.ahrq.gov/news/newsletters/research-activities/jan10/0110RA1.html  Accessed 13 Feb. 2017

26

Celox hemostatic gauze is approved by the Department of Defense for military use.

27

Kauvar, D.S., Lefering, R., and Wade, C.E.  Impact of hemorrhage on trauma outcome: an overview of epidemiology, clinical presentations, and therapeutic considerations. J Trauma. 2006;60: S3-11

28

Arul GS, Bowely DM, DiRusso S.  The use of Celox Gauze as an adjunct to pelvic packing in otherwise uncontrollable pelvic haemorrhage secondary to penetrating trauma.  J R Army Med Corps 2012. 158(4): 331-334.

29

Quayle JM, Thomas GOR.  A Pre-hospital Technique for Controlling Haemorrhage from Traumatic Perineal and High Amputation Injuries.  JR Army Med Corps 157(4): 419-420.

30

Bennett BL, Littlejohn LF, Kheirabadi BS, Butler FK, Kotwal RS, Dubick MA, Bailey JA. Management of External Hemorrhage in Tactical Combat Casualty Care:

Chitosan-Based Hemostatic Gauze Dressings, TCCC Guidelines – Change 13-05. J Special Operations Medicine. 2014; 14(3): 12-29.

31

National Trauma Institute :
http://www.nationaltraumainstitute.com/home/trauma_statistics.html . Accessed 14 Feb 2017.

32

From Center for Disease Control and Prevention.

https://www.cdc.gov/injury/wisqars/overview/key_data.html . Accessed 14 Feb 2017.

33

Koksal O et l. Hemostatic effect of a chitosan linear polymer (Celox) in a severe femoral artery bleeding rat model under hypothermia or warfarin therapy. Turk J Trauma & Emerg Surg. 2011; 17:199-204.

34

Millner R, Lockhart AS, Marr R. Chitosan arrests bleeding in major hepatic injuries with clotting dysfunction: an in vivo experimental study in a model of hepatic injury in the presence of moderate systemic heparinisation. Ann R Coll Surg Engl. 2010; 92(7): 559–561

35

Muzzi et al Successful use of a military haemostatic agent in patients undergoing extracorporeal circulatory assistance and delayed sternal closure.  Interact Cardiovasc Thorac Surg. 2012;14(6):695-8.

36

Rao SB, Sharma CP. Use of chitosan as a biomaterial: studies on its safety and hemostatic potential. J Biomed Mater Res. 1997; 34(1):21-8

37

Aiba S. Studies on chitosan: 4. Lysozymic hydrolysis of partially N-acetylated chitosans. Int J Biol Macromol 1992 vol 14, August.

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*

Combat Gauze Trademark of Z-Medica

**

Chitogauze Trademark of Hemcon

***

Bolin Trademark of H&H Medical Corporation

****

Halo Trademark of Medical Devices inc

 

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