A Prospective, Randomized, Double-Blind Trial of the Use of Fibrin Sealant for Face Lifts

Oliver and colleagues present their findings with the use of a commercially prepared fibrin sealant (Beriplast P) in face lifts. Although there have been published reports of the use of fibrin sealants in plastic surgery, this is the first that was performed as a prospective randomized study. The authors discuss the background and mechanism of action of fibrin sealants in surgery, and describe their method for the preparation and application of the fibrin sealant. The technique they describe meets many of the above-mentioned criteria. It is simple to use, convenient in that it is an off-the-shelf product, and relatively safe. Their findings show this product to be effective in reducing postoperative drainage in face lift surgery.

The discussion raises some issues regarding the use of material derived from blood products in elective cosmetic procedures. The authors mention a theoretical risk of disease transmission. However, there are some serious issues regarding the use of material derived from human blood donors. The risk of disease transmission, although remote, is not zero but real. There have been at least two case reports of disease transmission with the use of fibrin glue, one involving the transmission of parvovirus B19 infection with the same preparation used in this study (Beriplast) 1 and one involving the transmission of human immunodeficiency virus following the use of a cryoprecipitate-based form of fibrin glue. 2 Commercial fibrin glue systems use random donor homologous cryoprecipitate. Although the risk of disease transmission by these preparations is minimized by screening plasma donors, testing for certain viral infections, and heat treatment, these all serve to reduce but not eliminate the risk of disease transmission. Some viruses, including both the parvovirus B19 and the hepatitis A virus, have been shown to be particularly difficult to inactivate by the heat treatment processes used. 3 As new infectious diseases continue to emerge, there is also the possibility that such infectious agents may be transmitted by these products.

The mention of safety concerns with regard to the bovine source of the aprotinin used in the fibrin sealant used in this study in light of recent concerns with bovine spongiform encephalopathy is eye-opening. Very little attention, if any, has been paid in the United States to the bovine source of thrombin available, and thrombin is widely used in plastic surgical procedures, both on its own and as a component of fibrin sealants and platelet gels. The forthcoming introduction of recombinant human thrombin will help minimize this risk where thrombin is used.

The authors also discuss various strategies for the perioperative preparation of fibrin sealants and platelet gels, as well as the relative merits of these different preparations. The differences between a fibrin glue clot and an autologous platelet gel clot merits some discussion. A fibrin glue clot is composed of tightly cross-linked fibrin strands forming a dense matrix structure, which provides a scaffold into which fibroblasts can migrate. 4 The matrix, however, is bioactively passive in that it does not possess a mechanism to actively recruit undifferentiated cells into the scaffold. Although this does not affect the fibrin clot\'s hemostatic properties, it does affect its tissue regeneration properties. Additionally, the dense fibrin matrix architecture may actually inhibit healing 5 and make it difficult for new capillaries to penetrate newly formed tissue. A platelet gel clot consists of a far less dense fibrin matrix that is conducive to the ingrowth of new capillaries, plus a concentration of platelets that bind to each other and to the fibrin strands. It is the presence of the platelets that makes this a bioactive matrix. The platelets in the matrix, in addition to contributing to overall clot strength, play an important role in tissue healing. As the platelets become activated, they release a multiplicity of growth factors into the matrix, which actively attract undifferentiated cells into the matrix and trigger cell division in both fibroblasts and other undifferentiated cells. 6 To achieve a bioactive matrix with a platelet gel clot, it is important that the process used in obtaining the platelet concentrate yields viable platelets. Of the many methods for preparing autologous platelet gel, only the SmartPReP system (Harvest Technologies, Plymouth, Mass.) has published data documenting the platelet viability. 7

The authors are to be commended for describing and evaluating an effective and simple method of preparing fibrin sealant. Their use of patients as their own controls (i.e., using fibrin sealant on one side and using the contralateral side as the control) is to be commended. The occurrence of a hematoma in one patient requiring a return to the operating room on the side treated with fibrin glue emphasizes the fact that these substances are not a replacement for meticulous hemostasis and surgical technique, but rather surgical adjuncts.

The use of both fibrin sealants and platelet gels in plastic surgery should continue to grow, with the introduction of new, more effective, more convenient and, it is hoped, safer products and devices for their preparation. The use of autologous products (such as those prepared with the SmartPReP system) where possible is preferable because it eliminates the risk of disease transmission.