Surgical tissue adhesives are an ancient idea, going back to the beginnings of recorded history. The concept of adhering, rather than suturing, packing, or stapling planes of tissue is attractive, in that it is fast-acting and assures complete closure. Numerous technologies have been tried; some with limited success, others outright failures. In short, the perfect adhesive does not exist. Limitations occur in a number of areas: strength, toxicity, degradation, and safety. It is also important to keep in mind that "one size fits all" does not apply to adhesives in surgical applications any more than it does in day-to-day application. As one would not use paper glue to seal a bathtub, one would presumably not apply an adhesive onto tendons, which is suitable for sealing corneas. The properties required of an adhesive for each indication are quite different.
Over the last twenty-five years, advances have been made in a wide range of technologies targeting some embodiment of a practical and safe adhesive. Foremost and successful among these are cyanoacrylates, marine adhesive proteins, and fibrin-based sealants. Another promising adhesive technology is laser solders, a mixture of polypeptides and proteoglycans, which integrates with the repair site when laser energy is applied.
In light of these advances in the field, the Symposium for Surgical Tissue Adhesives was organized and held at the Atlanta Hyatt from October 8-10, 1993. The goal was to bring together these far-flung technologies in a comprehensive and cohesive manner. Presentations by investigators from around the world described the history of adhesives in medicine, current technologies, laboratory characterizations, and application developments, as well as regulatory aspects and clinical applications. We felt that as many viewpoints as possible, however conflicting, were important to present in order to give the most complete picture of the state of the art of surgical adhesives.
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About the Author
David H. Sierra, MS, Vice-President, Research and Development Cohesion Corporation Palo Alto, California, Renato Saltz, MD, FICS, FACS, Associate Professor of Surgery Division of Plastic and Reconstructive Surgery University of Utah Salt Lake City, Utah
Table of Contents
Preface, Contributing Authors, SECTION I — ADHESIVE TECHNOLOGIES, Chapter 1: History of Tissue Adhesives, Introduction, The Ideal Adhesive, Cyanoacrylate, Fibrin Sealant, Gelatin-Resorcinol-Formol (GRF) Glue, Mussel Adhesive Protein Prolamine Gel and Transforming Growth Factor Beta (TGF-β), Conclusion, References, Chapter 2: Commercial Pooled-Source Fibrin Sealant, Introduction, Production Issues, Product Safety, Application of Fibrin Sealants, Availability of Commercial Products, Conclusion, References, Chapter 3: Mussel Adhesive Protein, Introduction, Materials and Methods, Results, Discussion, Acknowledgements, References, Chapter 4: Fibrin-Collagen Composite Tissue Adhesive, Introduction, Materials and Methods, Effect of Collagen Preparation on Gelation (Thrombin) Time, Concentrations and Gelation Time Effects in Vitro, Viscosity o f Fibrinogen, Collagen and Composite Solutions; Prepolymerized, Viscoelastic Mechanical Properties, Dissolution Onset Time, Conclusion, References, Chapter 5: Soldering Is a Superior Alternative to Fibrin Sealant, Introduction, Materials and Methods, Laser System, Preparation of Adhesives/Solders, Animal Model, Analysis, Results, Discussion, References, SECTION II-LABORATORY EVALUATION, Chapter 6: Kinetic and Mechanical Parameters of Fibrin Glue, Introduction, Mechanism of Gel Formation, Kinetics of Gelation, Mechanical Properties, Viscoelasticity, Breaking Strength, Conclusion, Acknowledgement, References, Chapter 7: Surgical Tissue Adhesives: Host Tissue Response, Adhesive Strength and Clinical Performance, Introduction, Host Tissue Response to Adhesives, Biomechanical Testing of Adhesives, Clinical Efficacy, Final Comments, References, Chapter 8: Biological and Rheological Properties of a Virally Inactivated Fibrin Glue (Biocol®): Comparison to an Autologous Fibrin Glue, Introduction, Fibrin Glue Production, Biochemical and Biological Properties, Rheological Properties, Viral Safety and Validation, Clinical Applications, Regulatory Aspects, Conclusions, References, Chapter 9: Assessment of Restored Tissue Elasticity in Prolonged in vivo Animal Tissue Healing: Comparing Fibrin Sealant to Suturing, Introduction, Restored Biomechanical Tissue Integrity, Materials and Methods, Fibrin Sealant Preparations, Fibrin Sealant Application, In vivo Animal Tissue Sealant Closures, Tensile Constants—Measurements and Assessment, Results and Discussion, Tensile Testing Results, Tensile Break Strength, Tensile Strength, Tensile Elongation, References, Chapter 10: Veterinary Hemaseel®: Ex vivo and in vivo Studies on Bovine Fibrin Sealant, Introduction, Animal Safety Studies, Acute Topical Haemostasis Studies, Formulation, Animal Model, In vivo Studies of Wound Sealing and Healing, Preparation, Animal Model, Ex vivo Studies, Conclusion, Reference, SECTION III-LABORATORY APPLICATIONS, Chapter 11: Wound Healing Applications of Fibrin Sealants, Introduction, Biocompatibility Hierarchy, Ramifications in Implant Design: Fibrin Sealants, References, Chapter 12: Fibrin Sealant: A Versatile Delivery Vehicle for Drugs and Biologies, Introduction, Antibiotic Delivery from Fibrin Sealant, Delivery of Chemotherapeutics from Fibrin Sealant, Fibrin Sealant as a Delivery Vehicle for Osteoinducers, Delivery of Fibroblast Growth Factors from Fibrin Sealant, Delivery of Tributyrin from Fibrin Sealant, Conclusions, References, Chapter 13: Sustained Release of Antibiotics from Fibrin Sealant, Introduction, Materials and Methods, Fibrin Sealant, Tetracycline-Supplemented Fibrin Sealant, Tetracycline Release in Vitro, Measurement o f Tetracycline Concentrations, Linear Regression, Results, Kinetics of Release of TET from TET-FS, Discussion, References, Chapter 14: Bone Induction by Demineralized Bone Powder and Partially Purified Osteogenin Using a Fibrin-Sealant Carrier, Introduction, Materials and Methods, Fibrin Sealant (FS), Implant Preparation; DBP Study, Implant Preparation; Osteogenin Study, Animals, Surgery, Retrieval of Implants, Radiography, Radiomorphometry, Statistical Analysis, Histological Analysis, Results, Histology of Implants, Discussion, Conclusion, References, Chapter 15: Fibrin Sealant as a Delivery Vehicle for Sustained and Controlled Release of Chemotherapy Agents, Introduction, Materials and Methods, Reagents, Preparation ofFS + 5-FU Clots, Determination of 5-FU Release Kinetics, Statistics, Results, Duration of Delivery of 5-FU from FS Is Extended by the Use of the Anhydrous Form, Duration of Delivery of 5-FU from FS Is Proportional to the Mass of Anhydrous 5-FU, The Rate of Delivery of 5-FU from FS Is Constant under Limited-Sink Conditions, The Rate of Delivery of 5-FU from FS Is Constant under Infinite-Sink Conditions, Discussion, Conclusions, Acknowledgements, References, Chapter 16: Experimental and Clinical Considerations: Craniofacial Surgery and Bone Metabolism, References, SECTION IV-CLINICAL APPLICATIONS AND INVESTIGATIONS, Chapter 17: Fibrin Sealant and the U.S. Food and Drug Administration Review Process, Introduction, Investigational New Drugs, Product License Application, Fibrin Sealant, Conclusion, References, Chapter 18: Utilization of Fibrin Glue in Craniofacial and Facial Plastic Surgery, The Use of Sprayed Fibrin Glue in Facelifts, Use of Fibrin Glue in Craniofacial Surgery, References, Chapter 19: Tissue Adhesives in Plastic and Reconstructive Surgery, Introduction, Acrylate Adhesives, Fibrin Sealant, References, Chapter 20: Clinical Applications of Tissue Adhesives in Aesthetic and Reconstructive Surgery, Introduction, Functional and Aesthetic Reconstruction of Burned Hands, Aesthetic Reconstruction of Facial Bums, Grafting Wounds at Difficult Sites, Tissue Adhesives and Aesthetic Surgery, Tissue Adhesives and Endoscopic Surgery, Acknowledgement, References, Chapter 21: Surgical Adhesives in Otolaryngology, Summary, References, Chapter 22: A Review of Nonsuture Peripheral Nerve Repair, Introduction, Fibrin Glue, Historical Review, Composition of Fibrin Glues, Experimental Studies, Clinical Studies, Cyanoacrylates, Laser Welding of Nerves, Experimental Studies, Cell Surgery in Nerve Repair, The Future, References, Chapter 23: Clinical Use of Fibrin-Based Composite Tissue Adhesive in Otology and Neurotology, Introduction, Clinical Trials, Patients, Investigational Materials, Neurotologic Procedures, Otologic Procedures, Evaluation Procedure, Clinical Results, Conclusions, Acknowledgements, References, Chapter 24: Clinical Applications of Fibrin Sealant in Thoracic and Cardiovascular Surgery, Introduction, University of Virginia System, Methods of Application, TCV Uses of Fibrin Sealant, Recent Innovations, Complications, Conclusion, References, Index