FAQs

1. What is CELOX^TM?

CELOX^TM is a very effective haemostat granule. 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 international patent applications.

2. How does CELOX^TM work?

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 and can clot hypothermic or even heparinised blood¹.

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 detailing what country you are in with details about your intended use.

4. Is CELOX^TM a pharmaceutical?

No. CELOX^TM products are Class III CE Marked Medical Devices and approved by BSI.

5. Will CELOX^TM stop life-threatening bleeding?

Yes, if applied to the bleeding vessel CELOX^TM can stop life-threatening bleeding from a severed artery. This has been demonstrated independently in laboratory testing and evidenced in actual battlefield use³.

6. Will CELOX^TM clot blood containing anticoagulants such as heparin?

Yes, CELOX^TM has been tested and proven to clot blood containing heparin and Coumadin (generic name warfarin)^1,2,5.

7. Will CELOX^TM clot hypothermic blood?

Yes, CELOX^TM has been tested and proven to clot blood as cool as 15°C^1,2. BSI have reviewed these tests as part of our class III CE Mark.

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

Yes⁴. In cases of emergency bleeding, CELOX^TM should be left on the wound until the patient in seen by medical facility personnel. It can then be easily removed. Remove as much 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 has been shown to be broken down to basic sugars (glucosamine & n-acetyl glucosamine) by lysozyme, one of the body’s normal enzymes. 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 completely removed.

9. What shelf life does CELOX have?

CELOX^TM Granules and CELOX^TM-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.

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

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

11. Does CELOX^TM generate heat?

No. CELOX^TM has been tested and shown not to generate any increase in heat during blood clotting.

12. Are there any contraindications?

Please refer to specific product instructions for use

13. What if I get it in my eyes?

If eye irritation occurs, flush with water for five minutes.

14. 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.

15. 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.

16. 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 haemostatic agents that contain minerals such as Zeolite or Kaolin that are released as nanoscale powders when in contact with fluid.

17. 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.
Re-use potentially poses a risk of infection.

18. 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.

19. 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 haemostatics 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.

20. 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 mechanisms^1,5. 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.

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

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.

_References:

1. _{Medtrade data on file (In-vitro and in-vivo).}
2. _{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).}
3. _{Winstanley M, Smith JE, Wright C. Catastrophic haemorrhage in military major trauma patients: a retrospective database analysis of haemostatic agents used on the battlefield. J R Army Med Corps 2018;0:1-5 (retrospective study).}
4. _{Tan ECTH, Bleeker CP.: Field experience with a chitosan-based hemostatic dressing. MCI Forum 3(4): 11-15, 2011. (Clinical)}
5. _{Bar J, David A, Khader T, Mulcare M, Tedeschi C. Assessing coagulation by rotational thromboelastometry (ROTEM) in rivaroxaban- anticoagulated blood using hemostatic agents. Pre-hosp Disaster Med. 2017;32(5):580-587.}