Adjunctive use of surgical sealants and other securement products

The sealing and closure of wounds is imperative to ensure wound healing while minimizing the risk of contamination by debris and infectious agents, and minimizing scarring. Failure to use these products can lead to significant complications, infections, significant delays to healing, and potentially loss of life through infection of the tissue leading to septicemia.  While surgical dressings have become increasingly sophisticated in speeding healing, especially for chronic wounds, and are often sufficient for partial thickness wounds, but surgical tapes or sutures are minimally necessary for all but minor lacerations.

Hemostats, sealants and glues have been shown to aid recovery and rehabilitation after invasive surgical procedures, to reduce morbidity associated with infection rates and post-surgical adhesions, and to reduce morbidity associated with specific procedures. For example, these products may be used to reduce the risk of deep vein thromboses resulting from tourniquet application to reduce bleeding during total knee replacements.

Hemostats and sealants have been demonstrated to have substantial cost-effective benefits during many surgical operations and the cost of these products are increasingly seen as minor in comparison with the time saved during the surgical procedure alone, even without taking into account rehabilitation. These products have been shown to be highly cost-effective for topical wound closure and there are also many potential internal applications for these products.

Use of cyanoacrylate glues for closure has established a considerable following in all regions of the world. Conservative accident and emergency costs for closure of a small bleeding trauma laceration with sutures, local anesthetic, antibiotic cream and suture removal kit are approximately $75 (before labor and time are included). Cyanoacrylate products can be used without anesthetic, without sutures, and since cyanoacrylate sloughs off the skin surface, without a removal kit. The FDA has approved cyanoacrylate products as having an anti-microbial outcome, which further reduces the cost of using them to approximately 30% of using sutures. Once labor and time are added this falls to 5%.

Effective hemostasis also demonstrates attractive cost attributes; hemostats can be used for rapid and effective control of bleeding during surgery, thus avoiding an element of the hourly cost of an operating room ($2,000 to $10,000 per hour). For example, a $115 hemostat needs to shave four minutes off the operating time to “pay its way.” Often, these materials can save from five minutes to two hours depending on procedure.

Sealants also have attractive health economic attributes. The most obvious cases come from specific procedures that have become the lead indications and focus for development programs in many companies. For example, air leaks during lung surgery lead to the need for extended hospitalization (up to 28 days) and more intensive care, as well as additional surgical procedures. Sealants are also commonly applied to avoid cerebrospinal fluid leakage during neurological and spine surgery; leakage of cerebrospinal fluid would otherwise result in infection (including meningitis), debilitating headaches and other problems. In addition, the surgeon uses significant direct time to achieve meticulously leak-proof closure of the dura. This can be avoided by expert and experienced application of appropriate sealant products.

Significant cost-effectiveness arguments can be made for products that avoid blood transfusions or reduce the quantities of blood transfusion products required. Approximately 8 million patients worldwide would benefit directly from increased usage of hemostats, sealants and glue products to reduce bleeding during cardiovascular, orthopedic, urologic, and other general surgical procedures. Units of blood cost approximately $180 each; however, the benefit of reducing transfusion requirement goes beyond this simple saving. Often, the real benefit is that appropriate hemostasis reduces the risk of mortality. For example, reducing blood loss during cardiovascular procedures in particular not only prevents the use of large volumes of donated blood (e.g., 5–10 units for dissection of aortic aneurysms) but significantly reduces mortality rates (which can be as high as 30% for aortic aneurysm procedures).

Adhesion-prevention products have been shown to significantly reduce post-surgical adhesions associated with gynecological, spinal, cardiovascular and orthopedic procedures. Post-operative adhesions can severely complicate subsequent interventions by making re-entry hazardous, and impeding orientation and visibility, which can lead to damaging the surrounding tissues or vessels. There may also be increased blood loss, and significantly longer operating time required to cut through the adhesions.

Source: "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015." Published October 2010.  (See Report #S180.)