Surgical wounds are projected to increase in number at an annual rate of 3.6%, but overall the severity and size of surgical wounds will continue to decrease over the next five-seven 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, closure of surgical wounds continues to be performed most often by ‘primary intent’; i.e., using products such as sutures, staples, or glues, where the two sides across the incision line are brought close and mechanically held together. Disadvantages of sutures include loosening of a suture, accidental cutting of a suture, the chance of a suture tearing through delicate tissues, knot slippage and unattractive scarring.
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 finding their place in the operating room, 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. The risk of surgical site infection (SSI) in the USA is approximately 2% for elective clean surgery. However, for surgical procedures which are not clean, and for other countries, the risk of SSI may be 10.7% or higher, depending on the procedure. Adjunctive surgical closure and securement products have been shown to reduce infection levels. As such, cyanoacrylate adhesives have been approved in the USA to help prevent post-surgical infections (among other functions). Other countries, such as the United Kingdom, are closely examining the effectiveness of using cyanoacrylate adhesives to help prevent postoperative infections.
Surgical hemostats, tissue sealants, and glues are used for a wide array of surgical procedures ranging from closure of skin wounds to significant hemostasis and 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; therefore, they 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 materials (such as Johnson & Johnson/Ethicon’s Surgicel or Medafor’s VitaSure) 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.
Approximately 114 million surgical and procedure-based wounds are created annually worldwide that offer potential for use of adjunctive surgical closure and securement products; approximately 36 million of these wounds are created during surgical procedures in the United States.
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 10%–15% of these procedures would benefit from increased use of newly developed adjunctive surgical closure and securement products.
The above is an excerpt from the 2012 MedMarket Diligence, LLC, Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017”.