Tissue sealant essentials

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Tissue sealant essentials

  1. 1. Hemostats & TissueHemostats & Tissue Sealants in SurgerySealants in Surgery Dr. B. K. IyerDr. B. K. Iyer
  2. 2. Why Hemostats & tissue sealantsWhy Hemostats & tissue sealants • Minimize blood lossMinimize blood loss • Improve visualizationImprove visualization • Save operative timeSave operative time • Reduce or avoid transfusionReduce or avoid transfusion • Manage anticoagulated patientManage anticoagulated patient • Avoid conversion of lap proceduresAvoid conversion of lap procedures • Prevent leakage of non-bloody fluidsPrevent leakage of non-bloody fluids • Decrease post-op drainage, infection &Decrease post-op drainage, infection & hospital length of stay.hospital length of stay. • Surgeons consider cost, application, sideSurgeons consider cost, application, side effects, and efficacy when choosing.effects, and efficacy when choosing.
  3. 3. Why Hemostats & tissue sealantsWhy Hemostats & tissue sealants • Hemostats stop bleeding either mechanically orHemostats stop bleeding either mechanically or by augmenting the coagulation cascade,by augmenting the coagulation cascade, • whereas tissue sealants are products thatwhereas tissue sealants are products that bind to and close defects in tissue.bind to and close defects in tissue. • Use of tissue sealants and hemostatic agentsUse of tissue sealants and hemostatic agents has allowed for increased use of minimallyhas allowed for increased use of minimally invasive techniques for complex surgeries.invasive techniques for complex surgeries. • Are of various types-Are of various types- • Fibrin glue products,Fibrin glue products, • Thrombin and gelatin matrix compounds,Thrombin and gelatin matrix compounds, • Bovine serum albumin and glutaraldehyde mixes,Bovine serum albumin and glutaraldehyde mixes, • Polyethylene glycol hydrogelsPolyethylene glycol hydrogels
  4. 4. Factors in determining choiceFactors in determining choice • Product costProduct cost • AvailabilityAvailability • StorageStorage • Procedural applicabilityProcedural applicability • Format (sponge, fabric,Format (sponge, fabric, powder, paste, liquid)powder, paste, liquid) • PreparationPreparation • DeliveryDelivery • Speed to hemostasisSpeed to hemostasis • Durability of hemostasisDurability of hemostasis • Source (bovine, porcine,Source (bovine, porcine, human, plant)human, plant) • ImmunogenicityImmunogenicity • Impact on infection/healingImpact on infection/healing • Absorption rateAbsorption rate • SwellingSwelling
  5. 5. Site CharacterizationSite Characterization • Area: large vs smallArea: large vs small • Intensity: light vs heavyIntensity: light vs heavy • Accessibility: open vs confinedAccessibility: open vs confined • Surface type: raw vs smoothSurface type: raw vs smooth
  6. 6. Compare HemostatsCompare Hemostats 1900 1950 20001900 1950 2000 Clamps Clips Sutures Direct Compression Bone waxClamps Clips Sutures Direct Compression Bone wax Electrocautery Laser Argon beamElectrocautery Laser Argon beam ORC Gelatin ThrombinORC Gelatin Thrombin Flowable gelatinFlowable gelatin Fibrin SealantsFibrin Sealants Synthetic SealantsSynthetic Sealants Surgeons today have anSurgeons today have an impressive set of tools toimpressive set of tools to manage intra-operativemanage intra-operative bleeding. But one fact: theybleeding. But one fact: they do know what to use when?do know what to use when?
  7. 7. Comparing HemostatsComparing Hemostats • Fibrin glue products provide topical hemostasis, haveFibrin glue products provide topical hemostasis, have sealant properties, and promote tissue approximation.sealant properties, and promote tissue approximation. • The granular nature of the thrombin and gelatin matrixThe granular nature of the thrombin and gelatin matrix compound allows conformation to the wound’s shape—compound allows conformation to the wound’s shape— the granules swell 10% to 20%, causing tamponade inthe granules swell 10% to 20%, causing tamponade in the wound bed on contact with blood or other fluid.the wound bed on contact with blood or other fluid. • BioGlue (bovine serum albumin and glutaraldehyde)BioGlue (bovine serum albumin and glutaraldehyde) works best in a dry-field application.works best in a dry-field application. • Polyethylene glycol hydrogels cause minimalPolyethylene glycol hydrogels cause minimal inflammation and allergic reactions with superiorinflammation and allergic reactions with superior hemostasis.hemostasis.
  8. 8. International players in HemostatsInternational players in Hemostats • Major Global Companies in Tissue SealantsMajor Global Companies in Tissue Sealants MarketMarket • 3M Company (USA)3M Company (USA) • Abbott Laboratories (USA)Abbott Laboratories (USA) • Advanced Medical Solutions Group plc (UK)Advanced Medical Solutions Group plc (UK) • Angiotech Pharmaceuticals, Inc. (Canada)Angiotech Pharmaceuticals, Inc. (Canada) • B. Braun Melsungen AG (Germany)B. Braun Melsungen AG (Germany)
  9. 9. Materials HandlingMaterials Handling • Mechanism of actionMechanism of action • Passive (aides platelet plug formation)Passive (aides platelet plug formation) • Active (aides fibrin clot formation)Active (aides fibrin clot formation)
  10. 10. Materials PropertiesMaterials Properties • Application formatApplication format • FabricFabric • Woven (suturable vs see-through)Woven (suturable vs see-through) • Non-woven (layers vs peanuts vs cigars)Non-woven (layers vs peanuts vs cigars) • FlowableFlowable • Paste (spread with fingers)Paste (spread with fingers) • Slurry (apply with syringe)Slurry (apply with syringe) • LiquidLiquid • Drip (controlled delivery)Drip (controlled delivery) • Spray (broad coverage)Spray (broad coverage)
  11. 11. Types of hemostatsTypes of hemostats • Haemostats have fallen into several categories:Haemostats have fallen into several categories: • 1.1. DermaBond®, a synthetic cyanoacrylateDermaBond®, a synthetic cyanoacrylate adhesive, is approved for topical application toadhesive, is approved for topical application to close skin incisions and lacerations.close skin incisions and lacerations. Cyanoacrylate adhesives set fast and have highCyanoacrylate adhesives set fast and have high strength, but form brittle plastics that do notstrength, but form brittle plastics that do not resorb. This limitation restricts their use toresorb. This limitation restricts their use to bonding the outer surfaces of skin together.bonding the outer surfaces of skin together.
  12. 12. Types of hemostatsTypes of hemostats • Haemostats have fallen into several categories:Haemostats have fallen into several categories: • 2.2. Tisseel®, a fibrin sealant, is approved forTisseel®, a fibrin sealant, is approved for use as an adjunct to hemostasis in surgery.use as an adjunct to hemostasis in surgery. Fibrin sealants have excellent hemostaticFibrin sealants have excellent hemostatic properties, but are derived from human and/orproperties, but are derived from human and/or animal blood products, set slowly, have lowanimal blood products, set slowly, have low strength, and lose their strength rapidly.strength, and lose their strength rapidly.
  13. 13. Types of hemostatsTypes of hemostats • Haemostats have fallen into several categories:Haemostats have fallen into several categories: • 3.3. A third category of tissue adhesivesA third category of tissue adhesives combines natural proteins such as collagen orcombines natural proteins such as collagen or albumin with synthetic cross-linking agentsalbumin with synthetic cross-linking agents such as gluraraldehyde. FDA approved onesuch as gluraraldehyde. FDA approved one such product, BioGlue®, in 2001 for use as ansuch product, BioGlue®, in 2001 for use as an adjunct to sutures and staples in vascularadjunct to sutures and staples in vascular surgery to repair large arteries. The aldehydesurgery to repair large arteries. The aldehyde cross-linking agents employed in suchcross-linking agents employed in such products (i.e., glutaraldehyde, formaldehyde)products (i.e., glutaraldehyde, formaldehyde) are known to cause adverse tissue reactionsare known to cause adverse tissue reactions
  14. 14. Types of hemostatsTypes of hemostats • Haemostats have fallen into several categories:Haemostats have fallen into several categories: • 4.4. DuraSeal®, a sealant product composed of aDuraSeal®, a sealant product composed of a synthetic polymer called polyethylene glycol, issynthetic polymer called polyethylene glycol, is a relatively weak sealant approved for use ina relatively weak sealant approved for use in neurosurgery. To date, none of the productsneurosurgery. To date, none of the products available in the U.S. for use inside the bodyavailable in the U.S. for use inside the body have found widespread acceptance amonghave found widespread acceptance among surgeons, for reasons ranging from their lack ofsurgeons, for reasons ranging from their lack of performance (based on properties such asperformance (based on properties such as adhesiveness, flexibility, and resorption rate),adhesiveness, flexibility, and resorption rate), complexity of use, or concerns about thecomplexity of use, or concerns about the perceived benefit to risk.perceived benefit to risk.
  15. 15. Tissue sealants - ApplicationsTissue sealants - Applications • OdontologyOdontology • CardiologyCardiology • NeurologyNeurology • OrthopedicsOrthopedics • Bone HealingBone Healing • Bone ReplacementBone Replacement • Cartilage RepairCartilage Repair • GastrointestinologyGastrointestinology • Pneumothoracic SurgeryPneumothoracic Surgery • UrologyUrology • Renal Sparing SurgeryRenal Sparing Surgery • OtologyOtology • Reconstructive SurgeryReconstructive Surgery
  16. 16. BleedBleed
  17. 17. BleedBleed Collagen,Collagen, ORCORC FlowableFlowable GelatinGelatin ThrombinThrombin FibrinFibrin SealantSealant
  18. 18. Hemostasis and Sealing MarketHemostasis and Sealing Market • CollagenCollagen • INSTAT MCHINSTAT MCH (Microfibrillar Collagen(Microfibrillar Collagen Hemostat) - J&JHemostat) - J&J • Avitene MCH – DavolAvitene MCH – Davol (Bard)(Bard) • ORC (OxidizedORC (Oxidized Regenerated Cellulose)Regenerated Cellulose) • Surgicel – J&J/EthiconSurgicel – J&J/Ethicon • GelatinGelatin • Gelfoam – Pfizer/BaxterGelfoam – Pfizer/Baxter • Surgifoam – J&JSurgifoam – J&J • Flowable GelatinsFlowable Gelatins • Floseal - BaxterFloseal - Baxter • Surgiflow - J&JSurgiflow - J&J • ThrombinThrombin • Thrombin – King PharmaThrombin – King Pharma • Evithrom – J&JEvithrom – J&J • Recothrom – ZymogeneticsRecothrom – Zymogenetics • Fibrin SealantsFibrin Sealants • Tisseel – BaxterTisseel – Baxter • Evicel – J&JEvicel – J&J • Synthetic SealantsSynthetic Sealants • Bioglue – CryolifeBioglue – Cryolife • Duraseal – TycoDuraseal – Tyco • CoSeal – BaxterCoSeal – Baxter • Omnex – J&J/EthiconOmnex – J&J/Ethicon (Europe only)(Europe only) • LifeBond – (FDA approvalLifeBond – (FDA approval pending)pending)
  19. 19. CostCost • Avitene powder $625 (5ml)Avitene powder $625 (5ml) • Avitene sheets $350-550Avitene sheets $350-550 • Surgicel $12-20Surgicel $12-20 • Gelfoam $80-120Gelfoam $80-120 • Floseal $262 (5ml)Floseal $262 (5ml) • Bovine Thrombin $80 (5ml)Bovine Thrombin $80 (5ml) • Evithrom $95 (5ml)Evithrom $95 (5ml) • Recothrom $110 (5ml)Recothrom $110 (5ml) • Tisseel $220 (4ml)Tisseel $220 (4ml) • Evicel $340 (4ml)Evicel $340 (4ml) • BioGlue $325 (5ml)BioGlue $325 (5ml) • CoSeal $630 (4ml)CoSeal $630 (4ml)

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