This page is designed to help address and answer Frequently Asked Questions (FAQs) about our products and provide additional details. Please do not hesitate to reach out to us directly with questions at (646) 417-8452 or at info@omni-stat.com.
This page is designed to help address and answer Frequently Asked Questions (FAQs) about our products and provide additional details. Please do not hesitate to reach out to us directly with questions at (646) 417-8452 or at info@omni-stat.com.
OMNI-STAT and Celox are very effective hemostatic agents optimized to stop bleeding fast. They are made of a proprietary composition which contains chitosan. Chitosan is a natural polymer extracted from shrimp shells and highly purified. The composition is protected by 3 patents within the US.
OMNI-STAT & Celox hemostatic granules are very high surface area flakes. When they come in contact with blood, they absorb fluid, swell, gel and concentrate platelets to form a robust mechanical gel-like clot that plugs the bleeding source and seals the wound. By creating a physical barrier and through the activation of platelets, OMNI-STAT and Celox stop bleeding and reduce the risk of re-bleed.1
Our products work independently of the body’s normal clotting mechanism2, work in hypothermic conditions3 and clot blood containing anticoagulants like Heparin & Warfarin2,4,5. More about how OMNI-STAT & Celox hemostatic agents work can be found at www.omni-stat.com.
No. They are indicated for topical temporary external use only.
OMNI-STAT & Celox are cleared for sale in the US for use under the supervision of a healthcare professional. For information on ordering our products and a list of suppliers please contact your sales representative or you can reach us at info@omni-stat.com for additional details.
No. They are classified and regulated by the FDA as unclassified Medical Devices.
Yes, they are cleared under several 510Ks
Yes, our products are indicated for controlling a range of bleeding from minor, moderate to severe bleeding.6 Please see product packaging for product specific indications.
Yes, our products have been tested and shown to clot blood containing anticoagulants such as Coumadin (Warfarin) and Heparin.2,4,5
Yes, they have been tested and proven to clot blood as cool as 56° Fahrenheit.3
All application information is provided on the product packaging. Instructions from the packaging are included below:
Product Size: 3g
Instructions for use:
Dressing Size: 4in x 4in
Product Size: 6g w/Applicator
Warnings: Not indicated for junctional wounds not amenable to pressure. The bleeding site must be visualized prior to application of Celox granules; blind application to a bleeding site should be avoided. Device is not intended for surgical use. Do not use in abdominal wounds and wounds not amenable to pressure. Loss of sterility potentially poses a risk of infection. Do not apply over eyes. If eye irritation occurs flush with water for 5 minutes. Contains chitosan from shellfish. Allergy studies show no adverse reaction to date. Data on file at Medtrade Products Ltd.
Dressing Size: 3in x 5ft
Dressing Size: 2in x 2in
Dressing Size: 15g
Yes – Five minutes after bleeding has stopped, gently remove any excess product. Use saline if required.
Granules – should be cleansed and removed from the wound using your standard wound cleansing protocol. If required product can be removed (physically) and then any residual irrigated away with water or saline.
Gauze – should be cleansed and removed from the wound using your standard wound cleansing protocol. If required gauze should be soaked with saline prior to removal (physically) and then any residual irrigated away with water or saline.
Celox Vascular Pad – To remove, gently peel away the adhesive bandage (if used) and gently remove the Celox Vascular Pad, using saline if required. Thoroughly irrigate wound, prior to initiation of standard wound protocol.
Tests on OMNI-STAT & Celox products have included examination of whether particles may enter the bloodstream, no evidence was found based on histologically examined tissue from the treated vessels in a swine model of lethal artery injury.7 Femoral artery injuries in ten swine were treated with Celox Gauze and these showed some granules on the outside of the treated vessel, as expected, but no particles inside the vessel walls. This is consistent with previous findings in other similar studies. Clay et al8 used an arterial catheter and showed diminished – but measurable – arterial pressure in the ipsilateral thigh, after treatment with Celox granules for extremity artery hemorrhage, indicating that circulation was not blocked. Kheirabadi9 also showed continued distal blood flow with Celox, even after the treated vessel was occluded by the treatment.
Chitosan is naturally broken down by lysozyme, an enzyme that converts Chitosan to glucosamine and N-Acetyl glucosamine, which undergoes rapid clearance by the liver and the kidney and is excreted in the urine.10
OMNI-STAT products have a 3-year shelf life from the manufacturing date. Celox-A has a 4-year shelf life and Celox Gauze products have a 5-year shelf life.
No. The efficacy of OMNI-STAT & Celox products cannot be guaranteed past the expiry date found on the packaging.
OMNI-STAT is indicated for minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and also for moderate and severe bleeding.
Celox is indicated for temporary external treatment for controlling moderate to severe bleeding.
No, our hemostatic products do not generate heat. Laboratory testing has demonstrated no temperature increase during use.
No, there are no contraindications. OMNI-STAT & Celox are not intended for internal use. They should not be used in the eyes and are not indicated for use in the mouth.
Do not apply product over eyes. If eye irritation occurs, flush the eyes with water for 5 minutes and repeat if irritation continues. OMNI-STAT & Celox absorb moisture when in contact with fluid and can absorb moisture from the surface of the eyes which causes irritation.
There have been no reported allergic reactions as a result of using our products since launch in 2006. The chitosan has been tested on individuals with suspected and confirmed shellfish allergy, none of the test subjects demonstrated any dermal sensitivity when tested against the chitosan material.11
Do not eat. OMNI-STAT & Celox are not recommended for consumption. OMNI-STAT & Celox absorb 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.
No, OMNI-STAT & Celox granules are macroscopic granular flakes prepared from Chitosan, a material derived from Chitin which is found naturally in the exoskeleton or shells of crustaceans.
No, the gauzes are a standard non-woven gauze. While they absorb fluid, they are not absorbable. The gauze serves as a delivery device for the granules, which are laminated onto the gauze.
OMNI-STAT & Celox products should be stored in the unopened pouch in dry conditions at ambient temperature. No special storage conditions are required or indicated on the product labelling.
Discard any remaining product after use as sterility will be compromised.
Our products are provided sterile for single use only. They can be used to treat several wounds on one casualty. Do not store unused opened packs for later use. Reuse could potentially pose a risk of infection. Product sterility and performance may be affected.
OMNI-STAT & Celox 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. OMNI-STAT & Celox are not approved for use inside of the mouth or on eyes.
References:
References: 1. Data on File Omni-stat Medical Inc - MTO-22-210
Please leave us your details as below and submit or send us an e-mail to: info@omni-stat.com
Please leave us your details as below and submit or send us an e-mail to: info@omni-stat.com
Please leave us your details as below and submit or send us an e-mail to: info@omni-stat.com
Please leave us your details as below and submit or send us an e-mail to: info@omni-stat.com
Please leave us your details as below and submit or send us an e-mail to: info@omni-stat.com
Please leave us your details as below and submit or send us an e-mail to: info@omni-stat.com
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