1. Hemostats & TissueHemostats & Tissue
Sealants in SurgerySealants in Surgery
Dr. B. K. IyerDr. B. K. Iyer

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

17. BleedBleed

18. BleedBleed
Collagen,Collagen,
ORCORC
FlowableFlowable
GelatinGelatin
ThrombinThrombin
FibrinFibrin
SealantSealant

19. 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)

20. 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)