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HemoStyp® Hemostatic Gauze is a collagen-like natural substance created from chemically treated cellulose. It is an effective hemostatic agent registered with the FDA to help control bleeding from open wounds and body cavities. The HemoStyp® hemostatic material contains no chemical additives, thrombin or collagen, and is hypoallergenic and bacteriostatic. When it comes in contact with blood it expands slightly and converts to a gel that subsequently dissolves into glucose and saline. Because of its purity and the fact it simply degradates to these end products, it does not cause significant delay in healing as do other hemostatic materials that may have a similar appearance.

Hemostatic Response to Bleeding

The normal hemostatic response to damaged fascular endothelium can be divided into three stages:

1) Initial vasoconstriction, 2) Platelet aggregation on and around the lesion and the formation of a platelet plug, and 3) Activation of the reactions of blood coagulation.

Platelet plugs can stop bleeding from the smallest vessels. When bleeding is from larger vessels, blood clot formation is required. Blood coagulation is the replacement of a relatively unstable platelet plug with a stronger, more resilient blood clot through a series of interdependent, enzyme-mediated reactions that bring about the generation of thrombin and the formation of fibrin from fibrinogen. This is accomplished through intrinsic and extrinsic pathways.

Intrinsic Pathway - All components necessary for the clotting process are located in blood. As such, proteins required for such clotting to take place are part of the intrinsic pathway of blood coagulation. The effectiveness of the intrinsic pathway is assessed with the activated partial thromboplastin time test (PTT).

Extrinsic Pathway - The pathway of blood coagulation activated by tissue factor, a protein extrinsic to blood, is known as the extrinsic pathway. Tissue factor and co-factor VII allow the activation of factor X. With the exception of factor VII, all components of the extrinsic pathway are also components of the intrinsic pathway. Activity of the extrinsic pathway may be assessed in the lab using the prothrombin time test (PT).

Efficacy

HemoStyp® Hemostatic Gauze is an essential ingredient in expediting hemostasis. Research has demonstrated that PPT and PT are both decreased (clotting time accelerated) with the presence of HemoStyp® Hemostatic Gauze in the wound. It is useful in both pathways.

1. The intrinsic pathway is initiated by the activation of factor XII to its enzyme form, factor XIIa. As HemoStyp® dissolves and comes in contact with iron in red blood cells, it forms negatively charged colloidal particles that promote the activation of blood coagulation factor XII. Unlike most other materials used for hemostasis, HemoStyp® increases blood viscosity even in patients with coagulation defects.

2. Injury to the blood vessel lining and contact of blood with tissues outside the vessel stimulates thrombin production.Thrombin causes platelet aggregation. Platelets exposed to thrombin secrete their granules and release their contents into surrounding plasma. Thrombin also initiates a reaction leading to a fibrin clot. In research studies, the texture and initial solid state of HemoStyp® slowed the blood flow and reduced the time in which thrombin was released into the wound. This increased platelet and whole blood adhesion rates, thereby improving hemostasis speed and function.

3. The enzyme form of clotting factor XII (factor XIIa) catalyzes the conversion of factor XI to its enzyme form (factor XIa). Factor XIa catalyzes the conversion of factor IX to activated form factor IXa in a reaction that requires calcium ions. Factor IXa assembles on the surface of membranes in complex with factor VIII. The factor IXa/ factor VIII complex requires calcium to stabilize certain structures on these proteins associated with their membrane-binding properties. Factor Xa forms a complex with factor V on membrane surfaces in a reaction that also requires calcium ions. In research studies, HemoStyp® not only adhered to calcium ions, but because its surface area initially increases as it dissolves, it also expanded contact surfaces with blood coagulation factors needing calcium, thus increasing its overall effectiveness.

4. HemoStyp® helps stabilize new clots by accelerating the formation of fibrin cross-linkages.

5. HemoStyp® increases whole blood viscosity significantly in a wound, thus promoting the aggregation of red blood cells. At the same time, it helps restrict the loss of red blood cells and platelets to accelerate hemostasis. Unlike other materials used for hemostasis, HemoStyp® increases blood viscosity even in patients with coagulation defects.

Application

HemoStyp® Hemostatic Gauze is applied by simply folding the gauze once or twice, depending on the size of the wound, and then putting it as far into the wound as possible. Putting a bandage on top of the gauze is optional and in many cases unnecessary. On smaller cuts, it may be helpful to first cut the Gauze in half before applying it to the wound. When this is done, it may not be necessary to fold it first. Since EMS work is pre-hospital, rinsing the gauze out with saline or water is not necessary. This is because after the patient reaches the hospital, a wound will be debrided and possibly reopened prior to suturing.

Indications for HemoStyp®

OTC: HemoStyp® is indicated for temporary external topical bleeding of minor cuts or lacerations.