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Wed, 05/27/2009 - 7:08am

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Selecting the proper hemostat is critical to control active bleeding at the surgical site. Now, a plant-based hemostat works to do this while addressing safety concerns during surgery.

The solution to controlling active bleeding at the target site, while minimizing the risk for infection and disease transmission, is finding a suitable surgical hemostat to help clot the blood and reduce the amount of blood loss, thus minimizing the need for additional blood products. When choosing a hemostat, there are few factors to keep in mind, including the product’s safety profile and degradation. HemoStase™ Absorbable Hemostatic Particles attempts to address the need to control active bleeding at the surgical site while offering an alternative to human- or animal-based blood products and hemostats.

When surgeons begin any procedure—big or small, routine or revolutionary—they want to know they have the tools they need to get the job done. With so much to handle in a given procedure, active bleeding at the surgical site is a concern that can and needs to be prevented in order to facilitate the surgeon successfully completing the operation.

Excessive active bleeding at the site causes a multitude of problems for surgeons and OR staff. In simple terms, bleeding can reduce visualization for the surgeon, making it difficult for the surgeon to work at the target site. However, according to Jeff Hoffman, Marketing Director of U.S. Surgical Sealants for CryoLife® in Kennesaw, GA, not only does excessive bleeding create an increased challenge for surgeons during the surgery, it poses critical health concerns for the patients.

"The real concern is the increased morbidity and mortality rates associated with excessive blood loss," Hoffman says. "Generally, excessive blood loss requires that the patient be given additional blood products. These products always present with a risk of disease transmission because they are human derived. If a patient needs a higher volume of blood products, then the associated risk is higher."

The solution to controlling active bleeding at the target site, while minimizing the risk for infection and disease transmission, is finding a suitable surgical hemostat to help clot the blood and reduce the amount of blood loss, thus minimizing the need for additional blood products. When choosing a hemostat, there are few factors to keep in mind, including the product’s safety profile and degradation.

According to the Institute for Healthcare Improvement, reported infection rates are approximately 11 percent, for certain types of operations, making the risk of disease or infection in patients a constant concern for OR staff. Just as replacing blood lost with additional blood products poses a higher risk of infection, human- or animal-based hemostats also increase the risk of disease transmission.

While donated blood used to repair blood lost in surgery is screened and tested for disease to help safeguard against transmitted infection, blood-product storage is another infection risk to keep in mind. A study published in October 2008 by the American College of Chest Physicians found blood stored for 29 days or more, nearly two weeks less than the current standard for blood storage, is linked to a higher infection rate in patients who received transfusions with the blood.

Another factor to consider is product degradation. The longer the hemostat remains in the body post-operatively, the more likely the body will go through a foreign body reaction. Increased scar tissue and health complications as a result of a foreign object in the body can hinder a patients’ recovery and increase the risk for infection.

A solution introduced recently by CryoLife is the product HemoStase™ Absorbable Hemostatic Particles. According to Hoffman, this hemostatic product attempts to address the need to control active bleeding at the surgical site while offering an alternative to human- or animal-based blood products and hemostats.

"HemoStase is plant-based," Hoffman explains, "which allows the product to be used on all patients without certain risks associated with many human- or animal-based  hemostats."

Further, the product degrades quickly so as not to encourage a foreign body response. As Hoffman explains, HemoStase is a plant-based starch that is broken down through enzymes, mainly amylase. The degradation process happens in approximately 48 hours, so the risk of a foreign body response is lessened. HemoStase is a powder, and when applied to the bleeding site in surgery, it does a few things:

  1. It rapidly extracts the fluids from the blood.
  2. This osmotic action causes the particles to swell and concentrates the red blood cells, platelets and other blood proteins creating a hemostatic plug.
  3. This plug effectively creates the scaffold for the formation of the fibrin clot.

HemoStase is also safe for use with autologous blood salvage systems, Hoffman stated, a blood salvage system that essentially “recycles” the patient’s own blood, another effective solution at reducing the need for additional blood products after the procedure.

In the end, while all products and hemostats should be used with caution in the field, the main idea behind HemoStase is its plant-based origins to reduce associated adverse events while still controlling active bleeding at the surgical site—helping to keep patients safe and surgeons operating efficiently.

Sources: http://www.ihi.org/IHI/Topics/PatientSafety/SurgicalSiteInfections/

http://esciencenews.com/articles/2008/10/28/old.blood.linked.infection

HemoStase Absorbably Hemostatic Particles Instructions For Use (IFU)

 

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