Frequently Asked Questions - OMNI-STAT®

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.

1.

What are OMNI-STAT & Celox?

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.

2.

How do our products work to stop bleeding?

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.

3.

Can OMNI-STAT or Celox be left inside the body?

No. They are indicated for topical temporary external use only.

4.

Where can I get the products?

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.

Ordering details

 

  • FG07730531 – OMNI-STAT Hemostatic granules 0.1oz (3) with exterior pouch – 10 pouches/carton
  • FG04530411 – OMNI-STAT Hemostatic gauze 4in x 4in (10.2cm x 10.2cm) pad – 10 pouches/carton
  • FG07734331 – OMNI-STAT Hemostatic gauze 2/3in x 4 3/4in (17mm x 120mm) pad – 10 pouches/carton
  • FG08838021 – Celox Gauze 3in x 5ft Z-Fold (7.6cm x 1.5m) – 10 pouches/carton
  • FG08832071 – Celox-A 0.2oz (6g) Applicator – 10 pouches/carton
  • FG08834081 – Celox Vascular 2in x 2in (51mm x 51mm) – 10 pouches/carton

5.

Are OMNI-STAT & Celox Pharmaceuticals?

No. They are classified and regulated by the FDA as unclassified Medical Devices.

6.

Are OMNI-STAT & Celox cleared for sale in the US?

Yes, they are cleared under several 510Ks

7.

Will OMNI-STAT & Celox stop severe bleeding?

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.

8.

Will OMNI-STAT & Celox clot blood containing anticoagulants such as Coumadin (Warfarin) or Heparin?

Yes, our products have been tested and shown to clot blood containing anticoagulants such as Coumadin (Warfarin) and Heparin.2,4,5

9.

Will OMNI-STAT & Celox clot hypothermic blood?

Yes, they have been tested and proven to clot blood as cool as 56° Fahrenheit.3

10.

How are OMNI-STAT & Celox applied?

All application information is provided on the product packaging. Instructions from the packaging are included below:

OMNI-STAT® Hemostatic Granules

Product Size: 3g

Instructions for use:

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

OMNI-STAT® Hemostatic Gauze

Dressing Size: 4in x 4in

  1. Peel open pouch and remove the folded gauze from pack.
  2. Blot away any excess blood or exudate from the wound.
  3. Apply pre-folded OMNI-STAT® hemostatic gauze onto wound to cover the entire bleeding area. OMNI-STAT should be applied directly to the source of bleeding. If bleeding source is below the wound surface, then OMNI-STAT can be unfolded and tightly packed into wound.
  4. Apply firm pressure for 1-3 minutes depending on severity of the bleeding.
  5. If bleeding continues apply firm pressure for a further 3 minutes. If gauze becomes saturated additional OMNI-STAT® hemostatic gauze can be used if required.
  6. OMNI-STAT® hemostatic gauze can be gently removed after 5 minutes. If necessary, use water or saline on the pad before removal.
  7. Discard any unused gauze after opening.

OMNI-STAT® Hemostatic Gauze

Dressing Size: ⅔in x 4¾in

  1. Peel open pouch and remove the folded gauze from pack.
  2. Blot away any excess blood or exudate from the wound
  3. Apply pre-folded OMNI-STAT hemostatic gauze directly to the source of bleeding
  4. Apply firm pressure for 1-3 minutes depending on severity of the bleeding.
  5. If bleeding continues apply firm pressure for a further 3 minutes. If gauze becomes saturated additional OMNI-STAT hemostatic gauze can be used if required.
  6. OMNI-STAT hemostatic gauze can be gently removed after 5 minutes. If necessary, use water or saline on the pad before removal.
  7. Discard any unused gauze after opening.

Celox-A Hemostatic Granules

Product Size: 6g w/Applicator

  1. Identify the point of bleeding and apply direct pressure. Swab excess blood where practical.
  2. Tear open Celox-A packet and select applicator.
  3. To prepare the applicator, remove clear plastic tab from the top of the applicator and insert the plunger into applicator barrel.
  4. When ready to apply, remove blue end cap from the applicator
  5. Insert applicator with plunger as far into wound as possible.
  6. Slowly push plunger in while withdrawing the applicator and release granules to fill above skin level. Additional applicators or granule packs may be used if necessary.
  7. Cover and apply FIRM pressure directly to the wound for 5 minutes. If bleeding persists apply additional pressure until bleeding stops.
  8. Secure with a dressing to maintain pressure on the wound. Discard any unused product.
  9. If not in a medical facility, seek medical care as soon as possible and show empty pack to medical personnel.

Celox 5ft Z-Fold Hemostatic Gauze

Dressing Size: 3in x 5ft

  1. Identify the point of bleeding and apply direct pressure. Swab excess blood where practical.
  2. Tear open pouch. Take out the Celox Z-Fold Gauze and take hold of one end of the z-folded gauze
  3. Tightly pack the unfolding Celox Z-Fold Gauze directly to the source of bleeding, feeding in the Celox Gauze until the wound is filled above skin level. Excess Celox Z-Fold Gauze can be cut or torn if necessary.
  4. Apply FIRM pressure directly to the wound for 3 minutes. If bleeding persists apply additional pressure until bleeding stops.
  5. Secure with a dressing to maintain pressure on the wound. Discard any remaining Celox Z-Fold Gauze.
  6. If not in a medical facility, transfer patient as soon as possible and show empty packet to medical personnel.

Celox Vascular Hemostatic Gauze

Dressing Size: 2in x 2in

  1. Remove the Celox Vascular pad from sterile package.
  2. Place Celox Vascular pad over the wound access site and point of compression. The side with the Celox granules should be placed down over the access site, with sheath still in place.
  3. Remove sheath, ensuring some blood contacts the Celox Vascular pad. Apply firm manual compression for 5 minutes or until hemostasis is achieved.
  4. Leave Celox Vascular pad in place. Apply adhesive bandage over pad if required.
  5. Celox Vascular pad may be left in place for up to 24 hours.
  6. To remove, gently peel away the adhesive bandage (if used) and gently remove the Celox Vascular pad, using saline if required.
  7. Thoroughly irrigate wound, prior to initiation of standard wound protocol.

11.

Can OMNI-STAT & Celox be easily removed from a wound?

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.

12.

Is there a known risk of thromboembolic activity?

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.

13.

What is the clearance pathway of chitosan?

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

14.

What is the Shelf life of OMNI-STAT & Celox?

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.

15.

Can I use OMNI-STAT & Celox past their shelf life?

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

16.

Are OMNI-STAT & Celox suitable to stop bleeding on minor wounds?

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.

17.

Do OMNI-STAT & Celox generate heat?

No, our hemostatic products do not generate heat. Laboratory testing has demonstrated no temperature increase during use.

18.

Are there any contraindications?

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.

19.

What happens if I get OMNI-STAT or Celox granules in the eyes?

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.

20.

Do people with shellfish allergies have allergic reactions to OMNI-STAT or Celox as a result of the chitosan?

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

21.

What happens if I accidentally consume OMNI-STAT or Celox?

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.

22.

Are OMNI-STAT & Celox considered a powder?

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.

23.

Are OMNI-STAT & Celox gauzes absorbable?

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.

24.

How do I store OMNI-STAT & Celox?

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.

25.

How many times can you use OMNI-STAT or Celox to treat wounds and how many wounds?

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.

26.

Can I use OMNI-STAT & Celox on the Head or Neck?

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:

  1. In Vivo and In Vitro Data on File at Omni-stat Medical Inc
  2. 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.
  3. Data on file at Omni-stat Medical Inc. Laboratory testing has shown the product to be effective in blood temperatures down to 56°F (13°C).
  4. 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.
  5. Snyder RJ, Sigal BD. The importance of hemostasis in chronic wound care: 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.
  6. OMNI-STAT & CELOX (product packaging).
  7. Rall JM, et al. Comparison of novel hemostatic gauzes with QuikClot Combat Gauze in a standardized swine model of uncontrolled hemorrhage. J Trauma Acute Care Surg 75(2) suppl 2 150-156 (2013)
  8. Clay JG, et al. Comparative testing of new hemostatic agents in a swine model of extremity arterial and venous haemorrhage. Military Medicine 2010; 175(4):280
  9. Kheirabadi BS, et al. Comparison of new hemostatic granules / powders with currently deployed hemostatic Products in a lethal model of extremity arterial haemorrhage in swine. J Trauma 2009:66(2):316-26
  10. MT-18-240 Omni-stat Clinical and Scientific Product Monograph Dec 2018
  11. MT-20-310 Allergenicity Potential of Celox – Omni-Stat Hemostatic Devices Position Statement

References: 1. Data on File Omni-stat Medical Inc

Contact

Omni-stat Medical Inc

New York – SoHo – Hudson Square,
101 Avenue of the Americas,
8th and 9th Floors,
New York, NY 10013,
USA

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