It looks like you are in North America YesNo

Frequently Asked Questions – OMNI-STAT™

1. What is OMNI-STAT™?

OMNI-STAT™ is a very effective hemostat granule optimised to stop bleeding fast. It is made of a proprietary composition which contains chitosan. Chitosan is a natural polymer extracted from shrimp shells and highly purified. The OMNI-STAT™ composition is protected by 3 patents within the US.

2. How does OMNI-STAT™ work to stop bleeding?

OMNI-STAT™ granules are very high surface area flakes. When they come in contact with blood, OMNI-STAT™ swells, gels, and sticks together to make a gel like clot, without generating any heat. It works independently of the body’s normal clotting mechanism, works in hypothermic conditions and clots blood containing the blood-thinning drug heparin1. More about how OMNI-STAT™ blood clotting agents work can we found at www.celoxmedical.com.

3. Can OMNI-STAT™ be left inside the body?

No. OMNI-STAT™ is for temporary external use only.

4. Where can I get more information about ordering and the product?

OMNI-STAT™ is cleared for sale in US for use under the supervision of a healthcare professional.

To find out more about OMNI-STAT™ including ordering and delivery, please contact omnistatenquiries@medtrade.co.uk. 

5. Is OMNI-STAT™ a Pharmaceutical?

No. OMNI-STAT™ is classified and regulated by the FDA as an unclassified Medical Device.

6. Is OMNI-STAT™ cleared for sale in the US?

Yes, it is cleared under several 510Ks

7. Will OMNI-STAT™ stop severe bleeding?

Yes OMNI-STAT™ includes an indication for use under the supervision of a healthcare professional for temporary external treatment for controlling moderate to severe bleeding.

8. Will OMNI-STAT™ granules clot blood containing anticoagulants such as Coumadin or Heparin?

Yes, OMNI-STAT™ granules have been tested and shown to clot blood containing warfarin (Coumadin) and heparin1.

9. Will OMNI-STAT™ clot hypothermic blood?

Yes, it will stop bleeding in cold conditions. OMNI-STAT™ has been tested and proven to clot blood as cool as 56° Fahrenheit1.

10. How is OMNI-STAT™ applied?

Granules

  1. Tear open the OMNI-STAT™ 3g pouch
  2. Blot away any excess blood or exudate from the wound
  3. Pour enough OMNI-STAT™ onto the wound to cover the entire bleeding area. OMNI-STAT™ should be applied directly to the source of the bleeding
  4. Quickly cover with gauze and apply firm pressure for 1 to 3 minutes depending on the severity of the bleeding.
  5. If bleeding continues apply pressure for 3 more minutes. If further OMNI-STAT™ is required use an additional pouch.
  6. Five minutes after bleeding has stopped, gently remove any excess OMNI-STAT™. Use saline if required
  7. Discard any unused OMNI-STAT™

Gauze

  1. Tear open the OMNI-STAT™ gauze pack
  2. Blot away any excess blood or exudate from the wound
  3. Apply pre-folded OMNI-STAT™ onto the wound to cover the entire bleeding area. OMNI-STAT™ should be applied directly to the source of the bleeding. If bleeding is below the wound surface, then OMNI-STAT™ gauze can be unfolded and tightly packed into the wound.
  4. Apply firm pressure for 1 to 3 minutes depending on the severity of the bleeding.
  5. If bleeding continues apply pressure for 3 more minutes. If OMNI-STAT™ gauze becomes saturated then use an additional OMNI-STAT™ gauze pack.
  6. OMNI-STAT™ gauze can be gently removed after 5 minutes Use saline if required
  7. Discard any unused OMNI-STAT™

11. Can OMNI-STAT™ be easily removed from a wound?

Yes – Five minutes after bleeding has stopped, gently remove any excess OMNI-STAT™. Use saline if required.

Granules – At first dressing change after use, OMNI-STAT™ should be cleansed and removed from the wound using your standard wound cleansing protocol. If required OMNI-STAT™ can be removed (physically) and then any residual irrigated away with water or saline.

Gauze pad – At first dressing change after use, OMNI-STAT™ should be cleansed and removed from the wound using your standard wound cleansing protocol. If required OMNI-STAT™ should be soaked with saline prior to removal (physically) and then any residual irrigated away with water or saline.

12. What Shelf life does OMNI-STAT™ have?

OMNI-STAT™ has a 3 year shelf life at manufacture. We have tested and proven that OMNI-STAT™ will still pass its original specification after 3 years aging.

13. Can I use OMNI-STAT™ past its shelf life?

No. The efficacy of OMNI-STAT™ products cannot be guaranteed past the expiry date found on the packaging.

14. Is OMNI-STAT™ suitable to stop bleeding on minor wounds?

OMNI-STAT™ is cleared for minor, moderate and severe bleeding.

15. Does OMNI-STAT™ generate heat?

No, OMNI-STAT(R) hemostatic products do not generate heat. OMNI-STAT(R) has been independently tested and shown not to generate any increase in heat during blood clotting.

16. Are there any contraindications?

OMNI-STAT™ is not intended for internal (surgical) use. OMNI-STAT™ should not be used in the eyes. It is not indicated for use in the mouth.

17. What happens if I get OMNI-STAT™ granules in my eyes?

Do not apply OMNI-STAT™ over eyes. If eye irritation occurs, flush the eyes with water for 5 minutes and repeat if irritation continues. OMNI-STAT™ absorbs moisture when in contact with fluid and can absorb moisture from the surface of the eyes which causes irritation.

Flushing with water will carry away any OMNI-STAT™ granules, and saturate any granules halting its ability to absorb moisture.
For the latest Safety Data Sheets please follow this link – Click here

18. Do people with shellfish allergies have allergic reaction to OMNI-STAT™as a result of the chitosan?

There have been no known or suspected allergic reactions as a result of using OMNI-STAT™ since its launch in 2006. The chitosan has been extensively tested on individuals with suspected and confirmed shellfish allergy, none of the test subjects demonstrated any dermal sensitivity when tested against the chitosan material.

19. Where can I find the latest safety data sheets?

Safety Data Sheets (SDS) can be downloaded from Celoxmedical.com following this link – Click here

20. What happens if I accidentally consume OMNI-STAT™?

Do not eat. OMNI-STAT™ is non-toxic but not recommended for consumption. OMNI-STAT™ absorbs moisture when in contact with fluid and can absorb moisture from the gut which may cause discomfort.

If ingested, drink copious amounts of water to avoid any discomfort.
For the latest Safety Data Sheets please follow this link – Click here

21. Is OMNI-STAT™ a powder?

No, OMNI-STAT™ granules are macroscopic granular flakes prepared from Chitosan, a material derived from Chitin which is found naturally in crustacean exoskeleton or shell. OMNI-STAT™ is different from some other hemostatic agents that contain minerals such as Zeolite or Kaolin that are released as nanoscale powders when in contact with fluid.

22. How do I store OMNI-STAT™?

OMNI-STAT™ products should be stored in dry conditions at ambient temperature and no special storage conditions are required or indicated on the product labelling.
Discard any remaining product after use as sterility will be compromised.
Reuse potentially poses a risk of infection.

23 How many times can you use OMNI-STAT™ to treat wounds and how many wounds?

OMNI-STAT™ products are provided sterile for single use. OMNI-STAT™ can be used to treat several wounds on one casualty. Do not store unused opened packs of OMNI-STAT™ for later use. Products sterility and performance may be affected.

24. Can I use OMNI-STAT™ on the Head or Neck?

OMNI-STAT™ can be used externally on the head (for injuries outside of the skull) and neck. Refer to your clinical guidelines and or training, for example: Treatment of injuries in these areas needs to consider the airway and major blood vessels that supply the brain and the risk of applying pressure to the brain and nervous tissue in the event of a fracture. OMNI-STAT™ is not approved for use inside of the mouth.

References

No.

Reference

Instances on the website.

TM

Trademark of Medtrade Products Limited

various

1

Data on file, Medtrade. In laboratory testing Celox was effective on heparinized blood and blood at 56 °F blood temperature.

FAQs page

2

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

Celox Gauze product page

3

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

Celox Gauze product page

4

Observed in laboratory testing. Medtrade data on file.

Celox Gauze product page

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

Celox Gauze product page

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.

Applicator product page

7

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

Granules product page

8

Product instructions for use.

Celox Rapid product page

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.

Celox Rapid product pages

10

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

Celox Rapid product pages

11

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

Silvapro burn wrap product page

12

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

Celox EMS product page

13

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

Survey.

Celox EMS product page

14

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

Celox EMS product page

15

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

Celox Vascular product page

16

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

Omni-stat product page

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.

About Celox N Am page

24

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

About Celox N Am page

25

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

First aid / 2g granules

26

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

First aid / 2g granules

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

Home page global

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.

About Celox page

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.

About Celox

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.

About Celox.

Military page

31

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

Celox EMS page.

32

From Center for Disease Control and Prevention.

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

US website, Stop the Bleed info page.

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.

How Celox works page

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

How Celox works page

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.

How Celox works page

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

Celox FAQs US.

37

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

How Celox works page.

Used By Professionals Everywhere

MilitaryCelox forMilitaryLaw EnforcementCelox forLaw EnforcementHospitalsCelox forHospitalsEmergency Medical ServicesCelox forEmergency Medical ServicesRemote MedicineCelox forRemote MedicinePublic AccessCelox forPublic Access

Contact Us

Medtrade Products Ltd
Electra House, Crewe Business Park, Crewe, UK, CW1 6GL

Social

Page approval ref: MT-17-040

© Medtrade Products Ltd 2018

This website uses Cookies to improve your browsing experience. View Cookies Policy

I'm fine with this