tissue sealants and hemostatic agents 00.ppsx

tissue sealants and hemostatic agents

1. Tissue Sealants And
Hemostatic Agents
LeemaK Alhussayen.

2. Why Use
Hemostatic
Agents?
Minimize blood loss.
Improve visualization.
Save operative time.
Reduce or avoid transfusion.
Manage anticoagulated patient.
Avoid conversion of lap procedures.
Prevent leakage of non-bloody fluids.
Decrease post-op drainage and infection.
Decrease hospital length of stay.

3. Factors in
Choosing a
Hemostatic
Agent
Product cost.
Availability.
Storage.
Procedural applicability.
Format (sponge, fabric,
powder, paste, liquid).
Preparation.
Delivery.
Speed to hemostasis.
Durability of hemostasis.
Source (bovine, porcine,
human, plant).
Immunogenicity.
Impact on
infection/healing.
Absorption rate.
Swelling.

4. Hemostasis
and Sealing
Market
Collagen:
INSTAT MCH (Microfibrillar
Collagen Hemostat) -J&J
AviteneMCH –Davol(Bard)
ORC (Oxidized Regenerated
Cellulose):
Surgicel–J&J/Ethicon
Gelatin:
Gelfoam–Pfizer/Baxter
Surgifoam–J&J
FlowableGelatins:
Floseal-Baxter
Surgiflow-J&J
Thrombin:
Thrombin –King Pharma
Evithrom–J&J
Recothrom–Zymogenetics
Fibrin Sealants:
Tisseel–Baxter
Evicel–J&J
Synthetic Sealants:
Bioglue–Cryolife
Duraseal–Tyco
CoSeal–Baxter
Omnex–J&J/Ethicon (Europe
only)
LifeBond–(FDA approval
pending)

5. Materials
Properties/
Handling
Mechanism of action:
Passive (aides platelet plug formation).
Active (aides fibrin clot formation).
Application format:
Fabric
Woven (suturablevs see-through).
Non-woven (layers vs peanuts vs cigars).
Flowable
Paste (spread with fingers).
Slurry (apply with syringe).
Liquid
Drip (controlled delivery).
Spray (broad coverage.

6. Site
Characterization
Area: large vs. small.
Intensity: light vs. heavy.
Accessibility: open vs. confined.
Surface type: raw vs. smooth.

7. hemostasis
Collagen,
ORC
Flowable
Gelatin
Thrombin
Fibrin
Sealant

8. Collagen
Instat
Instat
Collagen.
Absorbable
Hemostat
Sponge
InstatMCH
MicrofibrillarCollagen
Hemostat Powder
Avitene
Collagen
Sponge
(Absorbable
Hemostat
Sponge)
AviteneMCH
Flour
(Microfibrillar
Collagen Hemostat
Powder)

9. Collagen
INSTAT (J&J)
&
Avitene
(Davol)
Plant-derived.
Available as sponge or powder.
Can be used dry or wet, cut, sutured, wrapped.
Won’t adhere to wet instruments or gloves.
Hemostasis in 3-5 minutes.

10. Avitene
Applicators
Extended applicators available for deeper open or
laparoscopic application of Avitene.
Use a syringe of air to clear any product still in
applicator.

11. Oxidized
Regenerated
Cellulose
(ORC)
Advantages
•Multiple application
formats (mesh, knit,
fibrillar).
•Plant-derived.
•Minimal tissue reaction.
•Bactericidal.
•minimal sticking to
gloves or instruments.
Disadvantages
•Swelling can cause
pressure on adjacent
structures.
•Impairs bone healing.
Absorption: within 7-14 days (depending on
amount used, degree of saturation with blood).

12. Oxidized
Regenerated
Cellulose
(ORC)
Hemostasis in 6-8 minutes
Hemostasis in 3-4minutes
Hemostasis in 3-5 minutes

13. How Does
SURGICEL
Work?
Oxidized Regenerated Cellulose
(ORC) absorbs blood and become a
gel covering the site of vessel injury.
Creates an area of low PH causing
localized vasoconstriction.
Provide a matrix for platelet adhesion,
accelerating the formation of the
platelet plug that will form the
foundation of the fibrin clot.

14. Why is
SURGICEL
bactericidal ?
Contact with moisture trigger the
breakdown of cellulose and the release
of cellulosic acid.
This causes localized area of low PH (3.4
–3.7).
Under acidic conditions, bacteria
become less active.
This PH lowering effect remains until
the material is fully absorbed (7-14
dayes).

15. Oxidized
Regenerated
Cellulose
(ORC)
Can be passed down
endoscopic instruments
SURGICEL Fibrillar:
Can be shredded, compacted,
or moistened and molded to
various shapes

16. GELFOAM/
SURGIFOAM
SURGIFOAM
Absorbable Gelatin Powder
GELFOAM
Absorbable Gelatin Sponge
SURGIFOAM
Absorbable Gelatin Sponge

17. GELFOAM/
SURGIFOAM
Addition of thrombin or saline allows molding to
specific areas
Doesn’t stick to gloves instruments, can be
passed down endoscopic instruments
Fast hemostasis
Minimal foreign body reaction
Absorbs in4-6weeks

18. Flowable
Gelatin
Composition
Animal-derived gelatin
mixed with thrombin (or saline) in a flowableconsistency
Mood of action
Gelatin provides a matrix for platelet adhesion and
aggregation
Thrombin aids in fibrin clot formation
Will not work if the area is not actively bleeding

19. Action
Flowable
Mechanism
of Action
Applied to the tissue surface at the
base of the lesion. Its granules fill the
wound and conform to its shape.
Granules expand approximately 20%
within about 10 min and restrict the
flow of blood. Blood that percolates
through the spaces is exposed to high
A clot forms around the matrix
provided by the granules and remains
in place at the tissue surface.

20. Action
Flowable
Mechanism
of Action
Granules not incorporated in the
clot can and should be removed
with gentile irrigation
Absorbed within 6-8 w

21. Flowable
Gelatin
Advantages
•Rapid hemostasis
•Precise application.
•75% more tissue
contact than
traditional gelatin
sponge.
•Flowable.
•Absorbable in 4-8
weeks.
Disadvantages
•Allergic potential
(when bovine
thrombin is used).
•Swells 20% as it
absorbs fluid.
•Preparation time.
•Cost.

22. Flowable
Gelatin
SURGIFLO
Uses human thrombin
Low risk of immune
reaction
Prep time: 30 minutes
FLOSEAL
Uses bovine thrombin
Higher risk of immune
reaction
Prep time: 60 minutes

23. Flowable
Gelatin
Indicated for the endoscopic delivery of hemostatic
agents
Narrow cannula allows precise application of more
product
Use stylet or syringe with air to express any
remaining product out of applicator
reusable

24. Thrombin
Bovine
Purified from pooled bovine plasma.
Not 100% homologous with human thrombin.
Bovine thrombin & factor V contain carbohydrate
groups that are inherently immunogenic in humans.
Recombinant Human
Human prothrombin gene is spliced into Chinese
hamster ovary (CHO) cells.
CHO cells make human prothrombin.
Prothrombin activated with snake venom enzyme
(cleaves prothrombin to thrombin).
Human
Purified from pooled human.
Viral transmission risk.

25. Bovine
Thrombin
surgical procedures, Used in a wide variety of surgical
procedures, estimated >500,000 Americans exposed
each year
Anaphylactic deaths reported from use in vascular
surgery resulting in black box warning from FDA

26. Pooled
Human
plasma
pruducts
Primary risk Is pathogen transmission
In 1977, FDA banned all commercially prepared human
fibrinogen preparations because of the high rate of
disease transmission (HBV)
In 1998, FDA lifted this ban due to improved methods
for plasma protein purification

27. Fibrin
Sealants
1909 –The use of fibrin to facilitate hemostasis was
reported for the first time.
1944–Plasma derived fibrinogen and thrombin were
used to enhance adherence of skin grafts.
1972–Highly concentrated fibrinogen made from
frozen plasma used to perform nerve anastomosis.
1975 –First clinical reports of autologous fibrin sealant
published in Europe.
1981–Fibrin sealant consisting of human thrombin,
highly stabilized human fibrinogen with enriched factor
XIII introduced.

28. Fibrin
Sealants
Fibrin Sealants Target the Final Steps of the Coagulation Cascade

29. Thrombin &
Fibrinogen
Can be stored in separate vials at -18 C for 2 years or
refrigerated at 4 C for 30 days
Can be thawed at room temperature or in 37 C water
bath
Dual delivery systems design to prevent mixing of the
two until contact with the target tissue

30. Fibrin
Sealants
EVICEL:
Uses human
thrombin (all human
components)
Low risk of immune
reaction
No aprotininor
tansexamanicacid
Prep time <1 minute
Clear clot
Spray or drip
TISSEEL
Uses bovine
thrombin
Higher risk of
immune reaction
Contains aprotinin
Prep time 15
minutes
Cloudy white clot
Spray (syringe or
pressure delivery) or
drip

31. Fibrin
Sealants

32. Anti-
Fibrinolytics
Anti-fibrinolyticsinhibit the formation of plasmin from
plasminogen
Tisseelcontains aprotinin, an antifibrinolytic.
Plasminogen has been removed from Evicelthrough an
extra step in the manufacturing process and therefore
does not need an antifibrinolyticagent to prevent the
formation fibrin clot.

33. Indecations
TISSEEL
Adjunct to hemostasis in
surgeries involving
heparinized patients
undergoing
cardiopulmonary bypass.
treatment of splenic
injurydue to blunt or
penetrating trauma when
control of bleeding by
standard surgical
techniques is ineffective
or impractical.
an effective sealant in
closure of colostomies.
EVICEL:
Adjunct to hemostasis
for use in patients
undergoing surgery
when control of
bleeding by standard
surgical techniques is
ineffective or
impractical.

34. Fibrin
Sealants
Not indicated for treatment of severe or brisk bleeding.
Do not inject directly into vascular structures.
Can apply in multiple layers.
OK to use cautery or suture through layers of sealant.
Clot longevity is comparable for both Tisseeland
Evicel.

35. Synthetic
Sealents
Co-Sealand BioGluemost
commonly used.
Creates a shell over the
area applied.
Caution not to cover things
that will be removed.

36. BioGlue
Composed of Glutaraldehyde and purified bovine
serum albumin (BSA).
Binds covalently to tissue surface proteins (won’t work
if place on non-protein surface).
Supplied with multiple syringe tips as they clot off as
soon as there is no active injection.

37. CoSeal
Composed of two synthetic polyethylene glycols
(PEGs) in hydrogen chloride and sodium phosphate.
When mixed the PEGS form a hydrogel that adheres to
tissue and covalently bonds to itself.
Completely synthetic no gluteraldehyde.
Swells up to 4 times its volume in 24 hrsand additional
swelling may occur as the gel resorbs.

38. Thank you.