FAQs

1. What is CELOX^TM?

CELOX^TM 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. CELOX^TM’s composition is protected by 3 patents.

2. How does CELOX^TM work to stop bleeding?

CELOX^TM Granules are very high surface area flakes. When they come in contact with blood, CELOX^TM 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. 

3. Where can I get the product?

CELOX^TM is sold through a network of distributors. To find out who represents CELOX^TM in your area, please contact celoxenquiries@celoxmedical.com with details about your intended use.

4. Is CELOX^TM a Pharmaceutical?

No. CELOX^TM is classified and regulated by the FDA as 510K cleared medical devices.

5. Will CELOX^TM stop moderate to severe bleeding?

Yes, our products are indicated for controlling a range of bleeding from minor or moderate to severe bleeding⁴. Please see product packaging for product specific indications.

6. Will CELOX^TM granules clot blood containing anticoagulants such as Coumadin or Heparin?

CELOX^TM has been tested and shown to clot blood containing warfarin (Coumadin) and heparin^1,2,3,4. CELOX^TM Rapid X-Ray is effective in compromised blood resulting from trauma induced coagulopathy and in blood containing heparin^3,4.

7. Will CELOX^TM clot hypothermic blood?

CELOX^TM has been tested and proven to clot blood as cool as 56°F^3,5. CELOX^TM Rapid X-Ray is effective in blood temperatures down to 56°F^3,5.

8. How long can CELOX^TM be left in place on a wound?

CELOX^TM Rapid X-Ray can be left in place for up to 72 hours⁴.

However, other CELOX^TM products can be safely left on a wound for up to 24 hours – do not delay moving patient to definitive care. Case reports have shown CELOX^TM has been left in place for 24 hours where there was no re-bleed or leakage. We recommend leaving CELOX^TM in place until the patient is moved to definitive care

9. Can CELOX^TM be easily removed from a wound?

Yes. In cases of emergency bleeding, CELOX^TM should be left on the wound to stop bleeding until the patient is seen by medical personnel. It can then be easily removed. Remove as much of the gel like clot as possible by hand, then irrigate the wound with water or saline. In cases of minor bleeding CELOX^TM can be removed once the wound has stabilized. This can be as short as 10 minutes. Irrigate with water or saline. Chitosan is a natural polysaccharide (polymer made of sugars) and made of basic sugars (glucosamine & n-acetyl glucosamine).  CELOX^TM does NOT use non degrading procoagulant minerals or nano particles such as kaolin, smectite or zeolite, which will remain in the body indefinitely unless physically removed.

10. Can I use CELOX^TM past its shelf life?

No. The efficacy of CELOX^TM products cannot be guaranteed past the expiry date found on the packaging.

11. How much is needed to treat a severe wound?

All wounds are different, however the 5-foot gauze has been tested and stopped the bleeding from a major artery, as has the 15 g granules.

12. Is CELOX^TM suitable to stop bleeding on minor wounds?

CELOX^TM is cleared for minor bleeding.  There are a range of reasons why a “minor” bleed might be difficult to stop, or instances where time is crucial (for example in sports).

13. Will CELOX^TM adversely affect later wound healing?

No. CELOX^TM has been tested to show that wound healing continues normally after its use.

14. Does CELOX^TM generate heat?

No, CELOX^TM hemostatic products do not generate heat. CELOX^TM has been independently tested and shown not to generate any increase in heat during use⁴.

15. Are there any contraindications?

Please refer to specific product instructions for use

16. What happens if I get CELOX^TM granules in my eyes?

Do not apply CELOX^TM over eyes. If eye irritation occurs, flush the eyes with water for 5 minutes and repeat if irritation continues. CELOX^TM 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 CELOX^TM granules and saturate any granules halting its ability to absorb moisture.

17. Which is the best CELOX^TM product for me to use?

The best version depends on your application. Please see specific product page for more information.

18. Do people with shellfish allergies have allergic reaction to CELOX^TM as a result of the chitosan?

There have been no known or suspected allergic reactions as a result of using CELOX^TM since its launch in 2006.

19. What happens if I accidentally consume CELOX^TM?

Do not eat. CELOX^TM is non-toxic but not recommended for consumption. CELOX^TM absorbs moisture when in contact with fluid and can absorb moisture from the gut which may cause discomfort. If ingested, drink water to avoid any discomfort.

20. Is CELOX^TM a powder?

No, CELOX^TM granules are macroscopic granular flakes prepared from Chitosan, a material derived from Chitin which is found naturally in crustacean exoskeleton or shell. CELOX^TM 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.

21. How do I store CELOX^TM?

CELOX^TM products should be stored in dry conditions at ambient temperature and no special storage conditions are required or indicated on the product labelling. Stability studies of CELOX^TM products stored at temperatures of 60°C and 40°C and freeze-thaw studies have been completed with no detrimental results to product or packaging reported.

Discard any remaining product after use as sterility will be compromised.
Reuse potentially poses a risk of infection.

22. How many times can you use CELOX^TM to treat wounds and how many wounds?

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

23. Can I use CELOX^TM on the head or neck?

CELOX^TM can be used externally on the head 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. CELOX^TM is not approved for use inside of the mouth or on eyes

24. Can I use CELOX^TM on the chest or abdomen?

Wounds to the chest or abdomen are generally classed as non-compressible. Most guidelines e.g. TCCC say do not use hemostatics on non-compressible wounds. Refer to your clinical guidelines and or training. In an extreme situation this requires clinical judgement. Use of CELOX^TM on this part of the body is not contraindicated. For penetrating chest injuries, the recommended treatment to prevent tension pneumothorax is to use an occlusive seal such as FOXSEAL^TM and FOXSEAL^TM Vented.

25. Does CELOX^TM work on patients with haemophilia / Von Willebrand Disease?

Von Willebrand disease is a genetic disorder caused by missing or defective Von Willebrand Factor (VWF) a clotting protein. VWF binds factor VIII, a key clotting protein, and platelets in blood vessel walls, which help form a platelet plug during the clotting process.

CELOX^TM works by purely physically means and does not rely on the body’s own blood clotting mechanisms⁴. While we do not have testing on patients with haemophilia, CELOX^TM has been tested on blood containing warfarin and heparin as well as being tested on hypothermic blood. In all of these cases CELOX^TM continued to work as well as on normal blood.

26. What Shelf life does CELOX have?

CELOX^TM Granules and CELOX-A Applicator have a shelf life of 4 years from the point at manufacture. CELOX^TM Gauze and CELOX^TM Rapid Gauze have a 5-year shelf life. Each product pack is marked with an expiration date.

_References:

1. _{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.}
2. _{Johnson L, Luksch P, Ranfield J, Hardy C. The laboratory assessment of a new hemostat able to clot blood containing anticoagulants. Presented at the 21st Annual Symposium on Advanced Wound Care and the Wound Healing Society, San Diego, 2008.}
3. _{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 (in-vivo).}
4. _{Medtrade data on file (In-vivo and in-vitro).}
5. _{Medtrade data on file. Laboratory testing has shown the product to be effective in blood temperatures down to 56°F (13°C).}