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Fibrin glue

January 01, 1970

Fibrin glue (also called fibrin sealant) is a surgical formulation used to create a fibrin clot for hemostasis, cartilage repair surgeries or wound healing. It contains separately packaged human fibrinogen and human thrombin.[8][9][10][11][12][13][14][15][16][17]

Fibrin glue
Fibrin glue applied after drying the scleral bed in an intraocular lens operation
Combination of
FibrinogenGlycoprotein
ThrombinCoagulation factor
Clinical data
Trade namesArtiss, Evicel, Tisseel, others
AHFS/Drugs.comProfessional Drug Facts
License data
Pregnancy
category
Routes of
administration		Topical
ATC code
Legal status
Legal status
Identifiers
CAS Number
  • 9001-32-5
  • 9002-04-4
DrugBank
  • DB09222
  • DB11571
UNII
  • N94833051K
  • 6K15ABL77G

Medical uses edit

This glue is used as a supportive treatment in surgery (such as liver surgery) for the improvement of hemostasis where standard surgical techniques are insufficient or impractical.[18][19]

It is also used for repairing dura mater tears and bronchial fistulas and for achieving hemostasis after spleen and liver trauma,[16] in "no sutures" corneal transplantation, pterygium excision with amniotic membrane or conjunctival autograft, and in eye trauma for corneal or conjunctival defects,[20][21][22] as well as for skin graft donor site wounds to reduce postoperative pain.[23]

It can also be used to treat pilonidal sinus disease but it is of unclear benefit as of 2017, due to insufficient research.[24]

Contraindications edit

The glue must not get into blood vessels, as this could lead to clotting in the form of thromboembolism or disseminated intravascular coagulation, or to anaphylaxis (a severe allergic reaction).[25]

Side effects edit

Possible adverse effects include bleeding disorder and allergic reactions such as flushing, stinging, generalised urticaria, angioedema, bronchospasm, and anaphylaxis. Other adverse effects in studies occurred in roughly equal proportions in treatment and placebo groups.[25]

Interactions edit

As fibrin glue contains proteins, it may be denatured by ethanol, iodine and heavy metals. These substances are frequently found in antiseptic solutions.[25]

Pharmacology edit

Mechanism of action edit

Thrombin is an enzyme that splits fibrinogen into fibrin monomers in 10 to 60 seconds, which aggregate to form a three-dimensional gel-like structure. Thrombin also activates factor XIII from the human body to factor XIIIa, which then cross-links the fibrin monomers to form a stable clot. Both these processes need calcium to work. As the wound heals, the clot is slowly degraded by the enzyme plasmin.[16][25][26]

Pharmacokinetics edit

In rabbit studies, only 1 to 2% of the applied thrombin dose reached the bloodstream. It reached highest blood plasma concentrations after 6 to 8 hours.[25]

Chemistry edit

Composition edit

Fibrin glue comes in two vials, respectively containing:

  • fibrinogen: lyophilised pooled human concentrate
  • thrombin: This used to be of bovine origin; modern formulations contain human thrombin.[11]

The two components are mixed immediately before application.[18][27] The formulations also contain calcium salts.[25]

Formulations from different manufacturers may also contain aprotinin, fibronectin, plasminogen, and factor XIII.[28][29]

Factors affecting structure edit

Factors that influence dimensional structure of fibrin gel giving rise to fine or coarse gel:

  • Changing concentration of fibrinogen
  • Changing concentration of thrombin – increased concentration increases ultimate tensile strength and Young modulus of gel
  • Changing concentration of calcium
  • pH
  • Temperature

History edit

A formulation with human thrombin was approved for medical use in the United States in March 2003, and in the European Union in October 2008.[18][27][30]

References edit

  1. ^ a b "VeraSeal". Therapeutic Goods Administration (TGA). 12 November 2021. Retrieved 28 December 2021.
  2. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Retrieved 13 May 2022.
  3. ^ "AusPAR: Human Fibrinogen / Human Thrombin". Therapeutic Goods Administration (TGA). 29 June 2022. Retrieved 17 July 2022.
  4. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
  5. ^ . (emc). 31 January 2020. Archived from the original on 10 July 2020. Retrieved 10 July 2020.
  6. ^ "Tisseel Ready to use Solutions for Sealant - Summary of Product Characteristics (SmPC)". (emc). 30 December 2019. Retrieved 10 July 2020.
  7. ^ "Artiss Solutions for Sealant - Summary of Product Characteristics (SmPC)". (emc). 29 January 2019. Retrieved 10 July 2020.
  8. ^ Irwin RM, Bonassar LJ, Cohen I, Matuska AM, Commins J, Cole B, Fortier LA (8 November 2019). "The clot thickens: Autologous and allogeneic fibrin sealants are mechanically equivalent in an ex vivo model of cartilage repair". PLOS ONE. 14 (11): e0224756. Bibcode:2019PLoSO..1424756I. doi:10.1371/journal.pone.0224756. PMC 6839864. PMID 31703078.
  9. ^ Shah NV, Meislin R (December 2013). "Current state and use of biological adhesives in orthopedic surgery". Orthopedics. 36 (12): 945–956. doi:10.3928/01477447-20131120-09. PMID 24579215.
  10. ^ Smith BL, Matuska AM, Greenwood VL, Gilat R, Wijdicks CA, Cole BJ (15 April 2022). "Autologous Fibrin Sealants Have Comparable Graft Fixation to an Allogeneic Sealant in a Biomechanical Cadaveric Model of Chondral Defect Repair". Arthroscopy, Sports Medicine, and Rehabilitation. 4 (3): e1075–e1082. doi:10.1016/j.asmr.2022.03.003. ISSN 2666-061X. PMC 9210474. PMID 35747626. S2CID 248208731.
  11. ^ a b Atrah HI (April 1994). "Fibrin glue". BMJ. 308 (6934): 933–934. doi:10.1136/bmj.308.6934.933. PMC 2539755. PMID 8173397.
  12. ^ Thompson DF, Letassy NA, Thompson GD (December 1988). "Fibrin glue: a review of its preparation, efficacy, and adverse effects as a topical hemostat". Drug Intelligence & Clinical Pharmacy. 22 (12): 946–952. doi:10.1177/106002808802201203. PMID 2468466. S2CID 37017252.
  13. ^ "Fibrin Glue for Anal Fistula - Digestive Disorders / Gastroenterology". MedHelp.
  14. ^ Shinohara K, Kobayashi E, Yoshida T, Toyama N, Kiyozaki H, Fujimura A, Miyata M (1998). "Effect of fibrin glue on small and large bowel anastomoses in the rat". European Surgical Research. 30 (1): 8–12. doi:10.1159/000008552. PMID 9493689. S2CID 46792418.
  15. ^ Spotnitz WD, Mintz PD, Avery N, Bithell TC, Kaul S, Nolan SP (August 1987). "Fibrin glue from stored human plasma. An inexpensive and efficient method for local blood bank preparation". The American Surgeon. 53 (8): 460–462. PMID 2440358.
  16. ^ a b c Saxena S, Jain P, Shukla J (2003). "Preparation of two component Fibrin Glue and its clinical evaluation in skin grafts and flaps". Indian J Plast Surg. 36 (1): 14–17.
  17. ^ Mücke T, Wolff KD (2009). "Performing microvascular anastomosis with fibrin glue--faster, easier, and more reliable?". Microsurgery. 29 (1): 80–81. doi:10.1002/micr.20556. PMID 18946885. S2CID 31854904.
  18. ^ a b c "Evicel EPAR". European Medicines Agency. 17 September 2018. Retrieved 12 June 2020.   This article incorporates text from this source, which is in the public domain.
  19. ^ "Evicel Fibrin Sealant (Human)". U.S. Food and Drug Administration (FDA). 22 July 2017.
  20. ^ Narendran N, Mohamed S, Shah S (July 2007). "No sutures corneal grafting--a novel use of overlay sutures and fibrin glue in Deep Anterior Lamellar Keratoplasty". Contact Lens & Anterior Eye. 30 (3): 207–209. doi:10.1016/j.clae.2007.02.007. PMID 17379570.
  21. ^ Dal Pizzol MM, Roggia MF, Kwitko S, Marinho DR, Rymer S (2009). "[Use of fibrin glue in ocular surgery]" [Use of fibrin glue in ocular surgery]. Arquivos Brasileiros de Oftalmologia (in Portuguese). 72 (3): 308–312. doi:10.1590/s0004-27492009000300006. hdl:10183/37501. PMID 19668958.
  22. ^ "Fibrin Sealant Fibrin Gluing Haemostasis autologous". vivostat.com.
  23. ^ Sinha S, Schreiner AJ, Biernaskie J, Nickerson D, Gabriel VA (November 2017). "Treating pain on skin graft donor sites: Review and clinical recommendations". The Journal of Trauma and Acute Care Surgery. 83 (5): 954–964. doi:10.1097/TA.0000000000001615. PMID 28598907. S2CID 44520644.
  24. ^ Lund J, Tou S, Doleman B, Williams JP (January 2017). "Fibrin glue for pilonidal sinus disease". The Cochrane Database of Systematic Reviews. 1 (1): CD011923. doi:10.1002/14651858.CD011923.pub2. PMC 6464784. PMID 28085995.
  25. ^ a b c d e f "Evicel: EPAR – Product Information" (PDF). European Medicines Agency. 12 June 2020.
  26. ^ Spotnitz WD (April 2010). "Fibrin sealant: past, present, and future: a brief review". World Journal of Surgery. 34 (4): 632–634. doi:10.1007/s00268-009-0252-7. PMID 19820991. S2CID 20760524.
  27. ^ a b "Evicel Fibrin Sealant (Human)- fibrinogen human and thrombin human kit". DailyMed. 17 December 2019. Retrieved 12 June 2020.
  28. ^ "Tisseel". Swedish official drug catalog.
  29. ^ KEGG drug: Factor XIII with fibrinogen. Accessed 9 July 2020.
  30. ^ "Evicel". U.S. Food and Drug Administration (FDA). 5 June 2017. Archived from the original on 22 July 2017. Retrieved 12 June 2020.

January 01, 1970
fibrin, glue, also, called, fibrin, sealant, surgical, formulation, used, create, fibrin, clot, hemostasis, cartilage, repair, surgeries, wound, healing, contains, separately, packaged, human, fibrinogen, human, thrombin, applied, after, drying, scleral, intra. Fibrin glue also called fibrin sealant is a surgical formulation used to create a fibrin clot for hemostasis cartilage repair surgeries or wound healing It contains separately packaged human fibrinogen and human thrombin 8 9 10 11 12 13 14 15 16 17 Fibrin glueFibrin glue applied after drying the scleral bed in an intraocular lens operationCombination ofFibrinogenGlycoproteinThrombinCoagulation factorClinical dataTrade namesArtiss Evicel Tisseel othersAHFS Drugs comProfessional Drug FactsLicense dataUS DailyMed EvicelPregnancycategoryAU B2 1 2 Routes ofadministrationTopicalATC codeB02BC30 WHO Legal statusLegal statusAU S4 Prescription only 1 3 CA only Schedule D 4 UK POM Prescription only 5 6 7 US only EU Rx only In general Prescription only IdentifiersCAS Number9001 32 59002 04 4DrugBankDB09222DB11571UNIIN94833051K6K15ABL77G Contents 1 Medical uses 2 Contraindications 3 Side effects 4 Interactions 5 Pharmacology 5 1 Mechanism of action 5 2 Pharmacokinetics 6 Chemistry 6 1 Composition 6 2 Factors affecting structure 7 History 8 ReferencesMedical uses editThis glue is used as a supportive treatment in surgery such as liver surgery for the improvement of hemostasis where standard surgical techniques are insufficient or impractical 18 19 It is also used for repairing dura mater tears and bronchial fistulas and for achieving hemostasis after spleen and liver trauma 16 in no sutures corneal transplantation pterygium excision with amniotic membrane or conjunctival autograft and in eye trauma for corneal or conjunctival defects 20 21 22 as well as for skin graft donor site wounds to reduce postoperative pain 23 It can also be used to treat pilonidal sinus disease but it is of unclear benefit as of 2017 due to insufficient research 24 Contraindications editThe glue must not get into blood vessels as this could lead to clotting in the form of thromboembolism or disseminated intravascular coagulation or to anaphylaxis a severe allergic reaction 25 Side effects editPossible adverse effects include bleeding disorder and allergic reactions such as flushing stinging generalised urticaria angioedema bronchospasm and anaphylaxis Other adverse effects in studies occurred in roughly equal proportions in treatment and placebo groups 25 Interactions editAs fibrin glue contains proteins it may be denatured by ethanol iodine and heavy metals These substances are frequently found in antiseptic solutions 25 Pharmacology editMechanism of action edit Thrombin is an enzyme that splits fibrinogen into fibrin monomers in 10 to 60 seconds which aggregate to form a three dimensional gel like structure Thrombin also activates factor XIII from the human body to factor XIIIa which then cross links the fibrin monomers to form a stable clot Both these processes need calcium to work As the wound heals the clot is slowly degraded by the enzyme plasmin 16 25 26 Pharmacokinetics edit In rabbit studies only 1 to 2 of the applied thrombin dose reached the bloodstream It reached highest blood plasma concentrations after 6 to 8 hours 25 Chemistry editComposition edit Fibrin glue comes in two vials respectively containing fibrinogen lyophilised pooled human concentrate thrombin This used to be of bovine origin modern formulations contain human thrombin 11 The two components are mixed immediately before application 18 27 The formulations also contain calcium salts 25 Formulations from different manufacturers may also contain aprotinin fibronectin plasminogen and factor XIII 28 29 Factors affecting structure edit Factors that influence dimensional structure of fibrin gel giving rise to fine or coarse gel Changing concentration of fibrinogen Changing concentration of thrombin increased concentration increases ultimate tensile strength and Young modulus of gel Changing concentration of calcium pH TemperatureHistory editA formulation with human thrombin was approved for medical use in the United States in March 2003 and in the European Union in October 2008 18 27 30 References edit a b VeraSeal Therapeutic Goods Administration TGA 12 November 2021 Retrieved 28 December 2021 Updates to the Prescribing Medicines in Pregnancy database Therapeutic Goods Administration TGA 12 May 2022 Retrieved 13 May 2022 AusPAR Human Fibrinogen Human Thrombin Therapeutic Goods Administration TGA 29 June 2022 Retrieved 17 July 2022 Health product highlights 2021 Annexes of products approved in 2021 Health Canada 3 August 2022 Retrieved 25 March 2024 TachoSil sealant matrix Summary of Product Characteristics SmPC emc 31 January 2020 Archived from the original on 10 July 2020 Retrieved 10 July 2020 Tisseel Ready to use Solutions for Sealant Summary of Product Characteristics SmPC emc 30 December 2019 Retrieved 10 July 2020 Artiss Solutions for Sealant Summary of Product Characteristics SmPC emc 29 January 2019 Retrieved 10 July 2020 Irwin RM Bonassar LJ Cohen I Matuska AM Commins J Cole B Fortier LA 8 November 2019 The clot thickens Autologous and allogeneic fibrin sealants are mechanically equivalent in an ex vivo model of cartilage repair PLOS ONE 14 11 e0224756 Bibcode 2019PLoSO 1424756I doi 10 1371 journal pone 0224756 PMC 6839864 PMID 31703078 Shah NV Meislin R December 2013 Current state and use of biological adhesives in orthopedic surgery Orthopedics 36 12 945 956 doi 10 3928 01477447 20131120 09 PMID 24579215 Smith BL Matuska AM Greenwood VL Gilat R Wijdicks CA Cole BJ 15 April 2022 Autologous Fibrin Sealants Have Comparable Graft Fixation to an Allogeneic Sealant in a Biomechanical Cadaveric Model of Chondral Defect Repair Arthroscopy Sports Medicine and Rehabilitation 4 3 e1075 e1082 doi 10 1016 j asmr 2022 03 003 ISSN 2666 061X PMC 9210474 PMID 35747626 S2CID 248208731 a b Atrah HI April 1994 Fibrin glue BMJ 308 6934 933 934 doi 10 1136 bmj 308 6934 933 PMC 2539755 PMID 8173397 Thompson DF Letassy NA Thompson GD December 1988 Fibrin glue a review of its preparation efficacy and adverse effects as a topical hemostat Drug Intelligence amp Clinical Pharmacy 22 12 946 952 doi 10 1177 106002808802201203 PMID 2468466 S2CID 37017252 Fibrin Glue for Anal Fistula Digestive Disorders Gastroenterology MedHelp Shinohara K Kobayashi E Yoshida T Toyama N Kiyozaki H Fujimura A Miyata M 1998 Effect of fibrin glue on small and large bowel anastomoses in the rat European Surgical Research 30 1 8 12 doi 10 1159 000008552 PMID 9493689 S2CID 46792418 Spotnitz WD Mintz PD Avery N Bithell TC Kaul S Nolan SP August 1987 Fibrin glue from stored human plasma An inexpensive and efficient method for local blood bank preparation The American Surgeon 53 8 460 462 PMID 2440358 a b c Saxena S Jain P Shukla J 2003 Preparation of two component Fibrin Glue and its clinical evaluation in skin grafts and flaps Indian J Plast Surg 36 1 14 17 Mucke T Wolff KD 2009 Performing microvascular anastomosis with fibrin glue faster easier and more reliable Microsurgery 29 1 80 81 doi 10 1002 micr 20556 PMID 18946885 S2CID 31854904 a b c Evicel EPAR European Medicines Agency 17 September 2018 Retrieved 12 June 2020 nbsp This article incorporates text from this source which is in the public domain Evicel Fibrin Sealant Human U S Food and Drug Administration FDA 22 July 2017 Narendran N Mohamed S Shah S July 2007 No sutures corneal grafting a novel use of overlay sutures and fibrin glue in Deep Anterior Lamellar Keratoplasty Contact Lens amp Anterior Eye 30 3 207 209 doi 10 1016 j clae 2007 02 007 PMID 17379570 Dal Pizzol MM Roggia MF Kwitko S Marinho DR Rymer S 2009 Use of fibrin glue in ocular surgery Use of fibrin glue in ocular surgery Arquivos Brasileiros de Oftalmologia in Portuguese 72 3 308 312 doi 10 1590 s0004 27492009000300006 hdl 10183 37501 PMID 19668958 Fibrin Sealant Fibrin Gluing Haemostasis autologous vivostat com Sinha S Schreiner AJ Biernaskie J Nickerson D Gabriel VA November 2017 Treating pain on skin graft donor sites Review and clinical recommendations The Journal of Trauma and Acute Care Surgery 83 5 954 964 doi 10 1097 TA 0000000000001615 PMID 28598907 S2CID 44520644 Lund J Tou S Doleman B Williams JP January 2017 Fibrin glue for pilonidal sinus disease The Cochrane Database of Systematic Reviews 1 1 CD011923 doi 10 1002 14651858 CD011923 pub2 PMC 6464784 PMID 28085995 a b c d e f Evicel EPAR Product Information PDF European Medicines Agency 12 June 2020 Spotnitz WD April 2010 Fibrin sealant past present and future a brief review World Journal of Surgery 34 4 632 634 doi 10 1007 s00268 009 0252 7 PMID 19820991 S2CID 20760524 a b Evicel Fibrin Sealant Human fibrinogen human and thrombin human kit DailyMed 17 December 2019 Retrieved 12 June 2020 Tisseel Swedish official drug catalog KEGG drug Factor XIII with fibrinogen Accessed 9 July 2020 Evicel U S Food and Drug Administration FDA 5 June 2017 Archived from the original on 22 July 2017 Retrieved 12 June 2020 Portal nbsp Medicine Retrieved from https en wikipedia org w index php title Fibrin glue amp oldid 1218288205, wikipedia, wiki, book, 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