Abstract
Fibrin biopolymers, previously referred as “fibrin glue” or “fibrin sealants”, are natural biomaterials with diverse applications on health. They have hemostatic, adhesive, sealant, scaffold and drug delivery properties and have become widely used in medical and dental procedures. Historically, these biomaterials are produced from human fibrinogen and human or animal thrombin, and the possibility of transmission of infectious diseases by human blood is not ruled out. In the 1990s, to overcome this problem, a new heterologous biomaterial composed of a thrombin-like enzyme purified from Crotalus durissus terrificus venom and a cryoprecipitate rich in fibrinogen extracted from buffaloes Bubalus bubalis blood has been proposed. Therefore, a systematic review of studies on exclusively heterologous fibrin sealants published between 1989 and 2018 was carried out using the following databases: PubMed, SciELO and Google Scholar. The keyword used was “heterologous fibrin sealant”. The search resulted in 35 scientific papers in PubMed, four in SciELO and 674 in Google Scholar. After applying the inclusion/exclusion criteria and complete reading of the articles, 30 studies were selected, which formed the basis of this systematic review. It has been observed that the only completely heterologous sealant is the one produced by CEVAP/UNESP. This heterologous biopolymer is proven effective by several studies published in refereed scientific journals. In addition, clinical trials phase I/II for the treatment of chronic venous ulcers authorized by the Brazilian Health Regulatory Agency (ANVISA) were completed. Preliminary results have indicated a safe and promising effective product. Phase III clinical trials will be proposed and required to validate these preliminary findings.
Highlights
Fibrin sealants are biological materials composed of fibrinogen and thrombin
In the 1990s, to overcome this problem, a new heterologous biomaterial composed of a thrombin-like enzyme purified from Crotalus durissus terrificus venom and a cryoprecipitate rich in fibrinogen extracted from buffaloes Bubalus bubalis blood has been proposed
The search resulted in 35 scientific papers in PubMed, four in SciELO and 674 in Google Scholar
Summary
Fibrin sealants are biological materials composed of fibrinogen and thrombin. In the presence of calcium and factor XIII, thrombin converts fibrinogen to soluble fibrin, forming a stable clot and mimicking the final step of the coagulation cascade. Sutures are the conventional technique in surgical procedures; due to the formation of fistulas, granulomas, tissue ischemia, and lacerations in some cases, tissue engineering has been stimulating the use of fibrin-based sealants [6] These products have been used in current clinical and surgical applications, mainly to approach the edges of the skin, to produce adherence to other tissues and to provide hemostasis [6,7,8,9]. Stolf et al [28] applied for the first time this new sealant in humans as an alternative to conventional suture in the nasolabial region, and described a good adhesive capacity and healing of this material After these conclusions, the researchers standardized the unique HFS using gyroxin – a serinoprotease obtained from the South American rattlesnake – and a cryoprecipitate extracted from Bubalus bubalis buffaloes [9,11]. Thereby, due to its clinical importance and increasing use in several health areas, the aim of this systematic review was to evaluate and compare studies on exclusively heterologous fibrin sealants produced worldwide
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