Surgical Procedures Worldwide with Potential for Use of Hemostats, Med/Surg Glues & Sealants and Adhesion Prevention

Sealant, Glues, Hemostats Potential ProceduresSurgical wounds are projected to increase in number at an annual rate of 3%, but overall the severity and size of surgical wounds will continue to decrease over the next five years as a result of the continuing trend toward minimally invasive surgery.

Surgical procedures generate a large number of uncomplicated acute wounds with uneventful healing, and a lower number of chronic wounds such as those generated by wound dehiscence or post-operative infection. On the skin surface, surgical wounds are most often closed by “primary intent”, using products such as sutures, staples, or glues, where the two sides across the incision line are brought close and mechanically held together. The use of glues for closure has rapidly become adopted for treatment of minor cuts and grazes over the last decade, and products in this category are now being promoted for use in theatre where they offer certain advantages over sutures. Benefits for use on the skin surface include reduced need for anesthesia, reduced infection, and reduced scarring.

A growing number of wounds created as part of the surgical procedure are becoming infected by pathogens that exhibit some resistance to antibiotics. Recent figures indicate that an average of 8% of wounds are infected in the hospital during surgical procedures. Adjunctive surgical closure and securement products have been shown to reduce infection levels, and, for example, cyanoacrylate adhesives have been approved in the USA for use to prevent post surgical infections.

Surgical hemostats, [tag]tissue sealant[/tag]s, and glues are used for a spectrum of surgical procedures ranging from closure of skin wounds to significant hemostasis to prevent blood replacement during major surgical procedures.

Hemostats are used to reduce bleeding during surgical procedures. These products work by coagulating blood quickly and accelerating the normal clotting mechanisms. Blood clotting is part of the body’s natural defense mechanism. After tissue damage, blood invades the damaged area. Platelets are activated to convert prothrombin into thrombin, which converts fibrinogen in the blood to form viscous polymers of fibrin. The fibrin is subsequently cross-linked by activated factor XIII to further bind the fibrin polymers into a viscous three-dimensional mat of fibrin. This is the basis of a blood clot which prevents further bleeding. Later in the healing process the fibrin clot is acted on by the enzyme fibrinolysin which breaks up fibrin as this material is no longer required. Fibrinolysis begins a cascade of healing by releasing fibrino-peptides which act to stimulate angiogenesis and cell-activated-repair.

The natural clotting process has been used by manufacturers to design new products that can mimic the body’s hemostatic action. Hemostatic products have been developed using collagen and degraded collagen (gelatin) to stimulate the hemostasis cascade. These hemostatic products depend on a cascade of blood factors to initiate and drive the full clotting process; they therefore tend to be slower-acting than products based on fibrin and thrombin which act later in the cascade to produce immediate hemostatic results. In addition, synthetic polyanionic materials (such as Johnson & Johnson/Ethicon’s Surgicel) and some naturally occurring biological polymers (such as calcium alginate and chitosan) have been developed to stimulate the same cascades; companies have recently evolved these simple hemostatic materials to develop hemostasis products that can also seal bleeding tissues.

[tag]Fibrin sealant[/tag]s and synthetic [tag]sealants[/tag] offer a significant advantage over pure hemostats because they do not rely on the full complement of blood factors to produce hemostasis. Sealants provide all the components necessary to prevent bleeding and will often prevent bleeding from tissues where blood flow is under pressure, and the damage is extensive.

In addition to [tag]hemostats[/tag] and sealants, a number of companies have developed tissue glues to reduce (and in some cases replace) the requirement for sutures. These products are capable of providing a degree of repair strength which is at least an order of magnitude greater than that achieved with [tag]fibrin[/tag] and synthetic sealants.

It is recognized that these products have potential to replace sutures in some cases where speed and strength of securement are priorities for the surgical procedure. Tapes, sutures and staples are also applicable to a growing range of procedure-specific internal securement cases

Approximately 70 million surgical and procedure-based wounds are created annually worldwide that offer potential for use of adjunctive surgical closure and securement products; over 20 million of these wounds are created during surgical procedures in the USA.

Although healing of all these wounds might be improved through use of adjunctive surgical closure and securement products, it is likely that increased usage of these products will be limited, on economic grounds, to a fraction of procedures. It is realistically estimated that some 10-15% of these procedures would benefit from increased use of newly-developed adjunctive surgical closure and securement products.

Tags: sealant, fibrin, hemostat, wound

See Report #S145: “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007.” Description and table of contents here.

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