Fibrin sealants: Surgical hemostat, sealant and adhesive

Expert Opinion on Biological Therapy

Volumn 14, Issue 6, 2014, Pages 821-830

  Mandell, Samuel P ^a   Gibran, Nicole S ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Adhesive; Fibrin sealant; Fibrinogen; Hemostasis; Sealant; Skin graft; Surgery; Thrombin

Indexed keywords

ADHESIVE AGENT; CYANOACRYLIC ACID OCTYL ESTER; ENBUCRILATE; FIBRIN GLUE; FIBRINOGEN PLUS THROMBIN; GELFOAM; HEMOSTATIC AGENT; MICROCRYSTALLINE COLLAGEN; OXIDIZED REGENERATED CELLULOSE; RECOMBINANT THROMBIN; SURGICAL GLUE; THROMBIN; TISSUE ADHESIVE;

AIR EMBOLISM; ANAPHYLAXIS; COCHRANE LIBRARY; COMPARATIVE STUDY; COST EFFECTIVENESS ANALYSIS; DRUG DELIVERY DEVICE; FIBRIN CLOT; FOOD AND DRUG ADMINISTRATION; GRAFT FAILURE; HEALTH CARE COST; HEMATOMA; HEMOSTASIS; HUMAN; MEDLINE; NONHUMAN; OPERATIVE BLOOD LOSS; PRURITUS; REVIEW; SAFETY; SKIN GRAFT; TISSUE ADHESION; WOUND CLOSURE; ANIMAL; BLOOD; BLOOD LOSS, SURGICAL; POSTOPERATIVE HEMORRHAGE; TREATMENT OUTCOME;

ANIMALS; BLOOD LOSS, SURGICAL; FIBRIN TISSUE ADHESIVE; HEMOSTASIS; HEMOSTATIC TECHNIQUES; HUMANS; POSTOPERATIVE HEMORRHAGE; TREATMENT OUTCOME;

EID: 84900795371     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1517/14712598.2014.897323     Document Type: Review

References (59)

1. Spotnitz WD. Fibrin sealant: past, present, and future: a brief review. World J Surg 2010;34(4):632-4
2. Baxter Corp. Package Insert: TISSEEL [Fibrin Sealant]. 2013. Available from: http://tisseel.com/us/pdf/TISSEEL-PI.pdf [Cited 5 January 2014]
3. Spotnitz WD, Burks S. Hemostats, sealants, and adhesives III: a new update as well as cost and regulatory considerations for components of the surgical toolbox. Transfusion 2012;52(10):2243-55
4. U.S Food and Drug Administration: vaccines, Blood, and Biologics Approved Products. 2013. Available from: http://www.fda.gov/BiologicsBlood Vaccines/BloodBloodProducts/ApprovedProducts/Licensed ProductsBLAs/ FractionatedPlasma Products/ucm127587.htm [Cited 4 January 2014]
5. Nogueira JF, Stamm A, Vellutini E. Evolution of endoscopic skull base surgery, current concepts, and future perspectives. Otolaryngol Clin North Am 2010;43(3):639-52; x-xi
6. Iribarne A, Easterwood R, Chan EY, et al. The golden age of minimally invasive cardiothoracic surgery: current and future perspectives. Future Cardiol 2011;7(3):333-46
7. Ha JF, Sieunarine K. Laparoscopic splenic artery aneurysm resection: review of current trends in management. Surg Laparosc Endosc Percutan Tech 2009;19(2):e67-70
8. LaPar DJ, Crosby IK, Ailawadi G, et al. Blood product conservation is associated with improved outcomes and reduced costs after cardiac surgery. J Thorac Cardiovasc Surg 2013;145(3):796-803; discussion 03-4
9. Horvath KA, Acker MA, Chang H, et al. Blood transfusion and infection after cardiac surgery. Ann Thorac Surg 2013;95(6):2194-201
10. Ferraris VA, Davenport DL, Saha SP, et al. Surgical outcomes and transfusion of minimal amounts of blood in the operating room. Arch Surg 2012;147(1):49-55
11. Lang N, Pereira MJ, Lee Y, et al. A blood-resistant surgical glue for minimally invasive repair of vessels and heart defects. Sci Transl Med 2014;6(218):218ra6
12. Brown AC, Barker TH. Fibrin-based biomaterials: modulation of macroscopic properties through rational design at the molecular level. Acta Biomater 2013. [Epub ahead of print]
13. Hedrich HC, Simunek M, Reisinger S, et al. Fibrin chain cross-linking, fibrinolysis, and in vivo sealing efficacy of differently structured fibrin sealants. J Biomed Mater Res B Appl Biomater 2012;100(6):1507-12
14. Lorentz KM, Kontos S, Frey P, Hubbell JA. Engineered aprotinin for improved stability of fibrin biomaterials. Biomaterials 2011;32(2):430-8
15. Pipan CM, Glasheen WP, Matthew TL, et al. Effects of antifibrinolytic agents on the life span of fibrin sealant. J Surg Res 1992;53(4):402-7
16. Rousou J, Levitsky S, Gonzalez-Lavin L, et al. Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations. A multicenter study. J Thorac Cardiovasc Surg 1989;97(2):194-203
17. Lowe J, Luber J, Levitsky S, et al. Evaluation of the topical hemostatic efficacy and safety of TISSEEL VH S/D fibrin sealant compared with currently licensed TISSEEL VH in patients undergoing cardiac surgery: a phase 3, randomized, double-blind clinical study. J Cardiovasc Surg (Torino) 2007;48(3):323-31
18. Saha SP, Muluk S, Schenk W III, et al. Use of fibrin sealant as a hemostatic agent in expanded polytetrafluoroethylene graft placement surgery. Ann Vasc Surg 2011;25(6):813-22
19. Saha SP, Muluk S, Schenk W III, et al. A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts. J Vasc Surg 2012;56(1):134-41
20. Vakalopoulos KA, Daams F, Wu Z, et al. Tissue adhesives in gastrointestinal anastomosis: a systematic review. J Surg Res 2013;180(2):290-300
21. Gibran N, Luterman A, Herndon D, et al. Comparison of fibrin sealant and staples for attaching split-thickness autologous sheet grafts in patients with deep partial-or full-thickness burn wounds: a phase 1/2 clinical study. J Burn Care Res 2007;28(3):401-8
22. Foster K, Greenhalgh D, Gamelli RL, et al. Efficacy and safety of a fibrin sealant for adherence of autologous skin grafts to burn wounds: results of a phase 3 clinical study. J Burn Care Res 2008;29(2):293-303
23. Hester TR Jr, Gerut ZE, Shire JR, et al. Exploratory, randomized, controlled, phase 2 study to evaluate the safety and efficacy of adjuvant fibrin sealant VH S/D 4 S-Apr (ARTISS) in patients undergoing rhytidectomy. Aesthet Surg J 2013;33(3):323-33
24. Hester TR Jr, Shire JR, Nguyen DB, et al. Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D 4 s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy. Aesthet Surg J 2013;33(4):487-96
25. Horowitz B, Busch M. Estimating the pathogen safety of manufactured human plasma products: application to fibrin sealants and to thrombin. Transfusion 2008;48(8):1739-53
26. Baxter Corp. Package Insert: ARTISS [Fibrin Sealant (Human)]. 2011. Available from: http://www.baxter. com/downloads/healthcare-professionals/ products/ARTISS-PI.pdf [Cited 5 January 2013]
27. Felema GG, Bryskin RB, Heger IM, Saswata R. Venous air embolism from Tisseel use during endoscopic cranial vault remodeling for craniosynostosis repair: a case report. Paediatr Anaesth 2013;23(8):754-6
28. Ebner FM, Paul A, Peters J, Hartmann M. Venous air embolism and intracardiac thrombus after pressurized fibrin glue during liver surgery. Br J Anaesth 2011;106(2):180-2
29. Umegaki T, Nishi K, Murao K, et al. [Lethal air embolism after spray of tissue adhesive-fibrinogen and factor XIII aerosol during laparoscopic partial nephrectomy]. Masui 2007;56(10):1203-5
30. Olsen PS, Hjelms E. Intravascular air after fibrin sealing by spray gun in cardiovascular surgery. Eur J Cardiothorac Surg 1989;3(4):376-7
31. Alving BM, Weinstein MJ, Finlayson JS, et al. Fibrin sealant: summary of a conference on characteristics and clinical uses. Transfusion 1995;35(9):783-90
32. US Food and Drug Administration. Guidance for Industry: efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use. 1999. Available from: http://www.fda.gov/cber/guidelines.htm [Cited 5 January 2014]
33. Jackson MR. Fibrin sealants in surgical practice: an overview. Am J Surg 2001;182(2 Suppl):1S-7S
34. Lowenfels AB. ACS 2006 Latest Advances in Surgical Adhesives. Medscape General Surgery. 2006. Available from: http://www.medscape.org/viewarticle/ 548909 [Cited 4 Januray 2014]
35. Spotnitz WD, Burks S. Hemostats, sealants, and adhesives: components of the surgical toolbox. Transfusion 2008;48(7): 1502-16
36. Llewellyn-Bennett R, Greenwood R, Benson JR, et al. Randomized clinical trial on the effect of fibrin sealant on latissimus dorsi donor-site seroma formation after breast reconstruction. Br J Surg 2012;99(10):1381-8
37. Yu L, Gu T, Song L, et al. Fibrin sealant provides superior hemostasis for sternotomy compared with bone wax. Ann Thorac Surg 2012;93(2):641-4
38. Carter TI, Fong ZV, Hyslop T, et al. A dual-institution randomized controlled trial of remnant closure after distal pancreatectomy: does the addition of a falciform patch and fibrin glue improve outcomes? J Gastrointest Surg 2013;17(1):102-9
39. Ding H, Yuan JQ, Zhou JH, et al. Systematic review and meta-analysis of application of fibrin sealant after liver resection. Curr Med Res Opin 2013;29(4):387-94
40. Knox CJ, Hohman MH, Kleiss IJ, et al. Facial nerve repair: fibrin adhesive coaptation versus epineurial suture repair in a rodent model. Laryngoscope 2013;123(7):1618-21
41. Randelli F, Banci L, Ragone V, et al. Effectiveness of fibrin sealant after cementless total hip replacement: a double-blind randomized controlled trial. Int J Immunopathol Pharmacol 2013;26(1):189-97
42. Rousou JA. Use of fibrin sealants in cardiovascular surgery: a systematic review. J Card Surg 2013;28(3):238-47
43. Sanjay P, Watt DG, Wigmore SJ. Systematic review and meta-analysis of haemostatic and biliostatic efficacy of fibrin sealants in elective liver surgery. J Gastrointest Surg 2013;17(4):829-36
44. Eriksen JR, Bisgaard T, Assaadzadeh S, et al. Randomized clinical trial of fibrin sealant versus titanium tacks for mesh fixation in laparoscopic umbilical hernia repair. Br J Surg 2011;98(11):1537-45
45. Wong JU, Leung TH, Huang CC, Huang CS. Comparing chronic pain between fibrin sealant and suture fixation for bilayer polypropylene mesh inguinal hernioplasty: a randomized clinical trial. Am J Surg 2011;202(1):34-8
46. Campanelli G, Pascual MH, Hoeferlin A, et al. Randomized, controlled, blinded trial of Tisseel/Tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial. Ann Surg 2012;255(4):650-7
47. Campanelli G, Sfeclan C, Cavalli M, Biondi A. Reducing postoperative pain: the use of Tisseel for mesh fixation in inguinal hernia repair. Surg Technol Int 2012;22:134-9
48. Vaid S, Nicholson T. A novel approach to closure of perineal wounds during abdominoperineal resection: use of fibrin sealant. Arch Surg 2012;147(8):778-80
49. Canonico S, Benevento R, Perna G, et al. Sutureless fixation with fibrin glue of lightweight mesh in open inguinal hernia repair: effect on postoperative pain: a double-blind, randomized trial versus standard heavyweight mesh. Surgery 2013;153(1):126-30
50. Healy C, Greig AV, Murphy AD, et al. Prospective randomized controlled trial: fibrin sealant reduces split skin graft donor-site pain. Plast Reconstr Surg 2013;132(1):139e-46e
51. Dhulkotia JS, Alazzam M, Galimberti A. Tisseel for management of traumatic postpartum haemorrhage. Arch Gynecol Obstet 2009;279(3):437-9
52. List RJ, Thomas SP, Shenouda E, et al. Fibrin Sealant Injection: an Aid to Reduce Venous Bleeding during Jugular Bulb and Sigmoid Sinus Dissection in Glomus Jugulare (Jugulotympanic Paraganglioma) Surgery. Skull Base 2011;21(5):309-12
53. Angioli R, Plotti F, Ricciardi R, et al. The use of novel hemostatic sealant (Tisseel) in laparoscopic myomectomy: a case-control study. Surg Endosc 2012;26(7):2046-53
54. Kim K, Park SI, Kim BJ, et al. Efficacy of fibrin sealant in reducing hemorrhage after a loop electrosurgical excision procedure. Gynecol Obstet Invest 2012;74(1):1-5
55. Carless PA, Henry DA, Anthony DM. Fibrin sealant use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev 2003;(2):CD004171
56. Mitra S, Khandelwal P, Roberts K, et al. Pain relief in laparoscopic cholecystectomy-a review of the current options. Pain Pract 2012;12(6):485-96
57. Tofuku K, Koga H, Yanase M, Komiya S. The use of antibiotic-impregnated fibrin sealant for the prevention of surgical site infection associated with spinal instrumentation. Eur Spine J 2012;21(10):2027-33
58. Cashman JD, Jackson JK, Mugabe C, et al. The use of tissue sealants to deliver antibiotics to an orthopaedic surgical site with a titanium implant. J Orthop Sci 2013;18(1):165-74
59. Figueras J, Llado L, Miro M, et al. Application of fibrin glue sealant after hepatectomy does not seem justified: results of a randomized study in 300 patients. Ann Surg 2007;245(4):536-42