HemCon Bandages work by becoming extremely adherent when in contact with blood. This adhesive-like action seals the wound and controls bleeding. HemCon products are fabricated from chitosan, a naturally occurring, bio-compatible polysaccharide. Because chitosan has a positive charge, it attracts red blood cells, which have a negative charge. The red blood cells create a seal over the wound as they are drawn into the bandage, forming a very tight, coherent seal. In addition to providing hemostasis, HemCon dressings also offer an antibacterial barrier. HemCon Bandages are an effective solution that reduces time to hemostasis, even for patients on anticoagulants.

HemCon ChitoFlex-Surgical is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

ChitoFlex® Hemostatic Surgical Dressings are simple to use, but key points need to be followed for the bandages to be most effective.

1. Remove HemCon ChitoFlex-Surgical from its packaging.
2. Cut dressing with sterile scissors to desired size. For best results, allow dressing to extend well beyond edges of the wound.
3. The dressing is most effective in the presence of enough blood to wet the contact surface of the dressing. However, excess pooling blood should be wiped from wound.
4. Avoid touching dressing with wet gloves, as the dressing may stick.
5. Apply dressing directly to the source of the bleeding. The dressing can be stuffed in the wound track of penetrating injuries.
6. Back the dressing with gauze and apply pressure for 2 minutes or until bleeding is controlled. Once dressing is in place, do not remove and attempt to replace.
7. After application, gauze will likely be stuck to dressing and can be left in place. Check for bleeding. If bleeding is observed, reapply pressure for another 2 minutes. If bleeding recurs, remove the dressing, clean the area of remaining chitosan material and apply another dressing.
8. Remove dressing within 24 hours by gently peeling from one edge and pulling away from patient. The dressing may turn a dark color after being in place. This is normal.
9. If dressing is difficult to remove, irrigate with sterile saline, wait several moments and re-attempt removal. Clean any remaining chitosan from surrounding area.

What was the impetus for the development of the ChitoFlex?
ChitoFlex was developed in 2006 out of a need to save lives. In 2001, the U.S. Army and the Institute for Surgical Research (ISR) partnered with HemCon Medical Technologies, Inc. to initially create the HemCon Bandage to address the needs of soldiers who were having bleeding issues and dying in the field before they could be triaged for surgical intervention. HemCon received the second fastest FDA clearance within 48 hours and HemCon Bandages have saved hundreds of lives since. After this development was complete, ChitoFlex was created to address additional wounds that required a dressing without a non-stick backing.

What is ChitoFlex™?
ChitoFlex is a 2-sided stuffable wound dressing that is active on both sides and can be used in hard-to-reach and narrow wound tracks. The product comes in a variety of sizes including: a 3 x 28 inch roll, a 3 x 9 inch roll, 1 x 3 inch strip and can be cut to fit without reducing efficacy.

From what is the ChitoFlex comprised?
ChitoFlex is fabricated from chitosan, a naturally occurring, biocompatible polysaccharide derived from shrimp shells. The shrimp shells are processed and chemically treated. Once in bandage form, they are sterilized.

Pandalus borealis (also called Pandalus eous) is the species of shrimp found in cold parts of the North Atlantic Ocean that is used in our chitosan. 

Is there a problem using this product on people with shrimp or shellfish allergies?
There have been no known allergic reactions as a result of using the HemCon Bandage since distribution began in 2003 and there have been no adverse effects reported in over one million bandages shipped.

HemCon has results from a shellfish allergy study conducted by its chitosan supplier which demonstrated that, out of 221 individuals with suspected hypersensitivity, including 8 individuals with known shellfish allergies, none demonstrated any dermal sensitivity when pricked with a chitosan test solution. However, since chitosan is extracted from the shells of shrimp and other shellfish, individuals with known shellfish allergies should exercise caution in the use of products containing chitosan.

How does ChitoFlex work?
The chitosan in ChitoFlex has a positive charge, and attracts red blood cells, which have a negative charge. The red blood cells create a seal over the wound as they are drawn into the dressing, forming a very tight, adherent seal. By quickly sealing the wound, the dressing reduces blood loss, and thus the demand for blood transfusion products such as red blood cells or plasma.

Can all HemCon Bandages be used internally?
HemCon Medical Technologies, Inc. also offers a variety of hemorrhage control dressings, but only ChitoFlex-Surgical is cleared with the FDA as a temporary surgical dressing to control severe bleeding in surgery and can therefore be left on the wound for up to 24 hours. All other HemCon Bandages from HemCon are FDA cleared as an external dressing for the temporary control of bleeding.   

Is the ChitoFlex absorbable?
No, ChitoFlex is not absorbable.

Who currently is using ChitoFlex?
The product is currently being used in the civilian market, by the U.S. Military, first responders, emergency departments and, as of July 2007, is exclusively offered to the hospital market by Cardinal Health.

Is ChitoFlex kosher?
ChitoFlex is made from shellfish, a creature that is considered forbidden from consumption by some religious groups. Although the dressing is not technically consumed, it is not considered kosher.

How long does it take for the dressing to control the bleeding?
ChitoFlex is durable, easy to use and capable of controlling hemorrhaging until an injured patient can be transported to and stabilized in a hospital. ChitoFlex controls bleeding within 2-5 minutes.

If ChitoFlex stops the bleeding, how does the wound heal?
ChitoFlex is cleared by the FDA for up to 48 hours of use to control severe bleeding and is not intended for long term application to promote wound healing. The dressing provides rapid control of severe bleeding by sealing the wound. The dressing functions independently of the clotting cascade. The body’s natural clotting occurs in conjunction with acute wound healing.

How long can ChitoFlex be left in place?
The dressing can be left in place for up to 48 hours.

How is ChitoFlex removed?
ChitoFlex can be easily removed with saline or water.

Is there any effect of cold temperatures on the dressing?
Although we would not expect low temperature storage conditions to affect dressing efficacy when used at room temperature and above, we have not conducted low temperature stability studies.

Is there any effect of hot temperatures on ChitoFlex?
ChitoFlex has a 3 year long shelf life and is durable in varied temperatures because it was originally designed for military use. ChitoFlex is best stored at room temperature: 52 degrees F (11 degrees C) to 78 degrees F (26 degrees C).
 

Will ChitoFlex work on hypothermic patients?
Although we would expect the dressing to work on hypothermic patients, we have not conducted any clinical studies to demonstrate efficacy.  

Are there any contraindications for its use?
There are no known contraindications for use of ChitoFlex. The warning and cautions on our product labels read as follows:

Do not use if seal is broken and/or contents are wet. Do not apply over eyes. Use promptly after opening. Contains chitosan from shellfish. For external use only, do not implant. Not for consumption, do not eat. Single use only. Do not resterilize.

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