The terms “sealant” and “glue” tend to be used interchangeably in the surgical context, but in fact there is a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products were the leaders.
Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and nonbleeding disorders. Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for hundreds of years. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. It is used for local hemostasis and as an augmenting material during arterial bleeding. It has been applied to every organ except eyeballs. It has been shown to be very useful for local hemostasis, a valuable tool for adhesion, sealing, anastomosis, vascular and nerve grafts, and many other procedures.
Fibrin and other sealant products have been approved and used outside the United States for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many such products have been marketed in these regions for up to 20 years and have been developed for a variety of surgical uses. While in the United States these products were approved initially as hemostatic adjuncts to suturing, they are increasingly being used for sealing of tissues, yet their use beyond hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the United States.
For the vast majority of surgical procedures, sutures and staples remain the most common methods of closure, but often they are sub-optimal. They do not have inherent sealing capabilities, and therefore cannot stop air and fluid leakage (for example in lung resection) and fluid leakage at the wound site. Furthermore, friable tissues such as the liver, brain or spleen, are fragile and often cannot support sutures or staples. Therefore, other means of wound closure are required for repair of these tissues.
Applications of Fibrin and Other Sealants
- Local hemostatic measures for both surgical and trauma cases
- Surgery in patients with bleeding disorders (e.g., hemophilia, severe thrombocytopenia) and non-bleeding cases with suspected fluid oozing
- Surgery in nonsuturable organs (e.g., brain, liver, lung, pancreas, thymus) or to repair unhealthy tissue (e.g., irradiated bowel or tissue of elderly patients)
- Cardiovascular, microvascular surgery and vascular grafts (e.g., aneurysm repair, coronary bypass, etc.)
- Nerve grafts
- Skin grafts, particularly plastic surgery
- Surgery of small or difficult to reach organs (e.g., tympanoplasty, ENT, eye)
- Sealing of body cavities, fistulae, pneumothorax, cranium, etc.
- Anastomosis of gastrointestinal, tract and other ductal organs
Source: MedMarket Diligence Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, 2009-2013."