CuraMedical Frequent Asked Questions about Absorbable Haemostats Fred J. Hoogland Director Marketing & Sales

The Absorbable Haemostat Family

Haemostasis Etymology: New Latin, Etymology: New Latin, –from Greek haimostasis styptic, –from haimo- hem- + -stasis Arrest of bleeding

Conventional procedures to control bleeding during surgical procedures Pressure Pressure Ligature (tying, binding, suturing) Ligature (tying, binding, suturing) Clip Clip Electro coagulation Electro coagulation

How to achieve or enhance haemostasis when conventional methods are ineffective or impractical? Large oozing surfaces (capillaries) Large oozing surfaces (capillaries) Poor access to the surgical site Poor access to the surgical site

Absorbable haemostatic agents

An absorbable haemostatic agent, surgical is: (Summary From the General and Plastic Surgery Devices Panel Meeting (Summary From the General and Plastic Surgery Devices Panel Meeting July 24, 2003 FDA) “a device intended to produce haemostasis by accelerating the clotting process of blood during surgical procedures” “a device intended to produce haemostasis by accelerating the clotting process of blood during surgical procedures” “the device is absorbable” “the device is absorbable” “the device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for haemostasis, when control of bleeding by pressure, ligature and other conventional procedures is ineffective or impractical” “the device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for haemostasis, when control of bleeding by pressure, ligature and other conventional procedures is ineffective or impractical”

Families of absorbable Haemostatic agents Gelatine Gelatine Oxidised (Regenerated) Cellulose (ORC) Oxidised (Regenerated) Cellulose (ORC) Collagen (reconstruction surgery) Collagen (reconstruction surgery) Thrombin (drug) Thrombin (drug) Glues with biological or synthetic fibrin sealants Glues with biological or synthetic fibrin sealants

Technical data GelatineOCCollagen OriginAnimalVegetalAnimal Produced from Porcine Rayon or cotton BovinePorcineEquine Extracted from Pig skin Wood pulp Cotton Skin (bovine or porcine Achilles tendon (bovine or equine)

How do haemostats agents provide haemostasis? GelatineOCCollagen Primary haemostatic action Extensive physical surface contact matrix for platelet adhesion Vasoconstriction Pressure from swelling Denatures blood proteins albumin and globulin Physical matrix for platelet adhesion Hyper activation of platelets and coagulation factors Time for haemostasis 2 – 3 minutes 2 – 8 minutes 1 – 2 minutes

To what extent are haemostats absorbent? GelatineOCCollagen Absorbency in times of it’s own weight 45 – 50 5 – – 80

Are all haemostats absorbable? GelatineOCCollagen Absorptiontime 4 – 6 weeks 1 – 2 weeks 5 – 8 weeks Absorptionconditions Always absorbable Absorption only possible when saturated with blood! Always absorbable Remark 3 days when in contact with mucous tissue

Are all haemostats safe? GelatineOCCollagen General Carefully read the instructions for use (Over) packing Packing material to fill cavities NeverNever Excess quantity RemoveRemoveRemove

Are all haemostats safe? GelatineOCCollagen pHNeutral Acid (pH < 3) Slightly Acid Swelling Back to original form after liquid absorbance Swelling can cause (undesired) pressure

Secondary effects? GelatineOCCollagen Secondary effects Risk of tissue fibrosis Interference with callus formation Bovine collagen allergy Interference with epithelialisation Decreases bonding effect of cement

Contraindications? GelatineOCCollagen Infected tissue Do not use Contra indications Over packing; Risk of embolisation (for powder) Packing and wadding; Spinal cord, optic nerves, Chiasm -low pH; Near nerves; Serous oozing surfaces Packing; Risk of allergy for bovine collagen

Are haemostats to be removed? GelatineOCCollagen Removal after haemostasis is achieved Only if over packing Packing and over packing and nearly in all indications Only if packing and over packing

Physical remarks? GelatineOCCollagen SuturingNoPossibleNo WrappingNoYesNo StickingNoNoYes Swelling No (only to it’s original form) YesYes Apply Dry, wet or impregnated Dry Dry or wet

Are all Haemostats compatible with drugs? Compatibility ↓ GelatineOCCollagen DrugsYesNoSomeantibiotics ThrombinYesNoPossible Biological sealants (glues) YesNoNo Synthetic sealants (glues) YesNoNo

Criteria to choose a haemostatic agent: Duration to obtain haemostasis?Duration to obtain haemostasis? Swelling?Swelling? Absorbency?Absorbency? Duration and conditions of absorption?Duration and conditions of absorption? Wrapping?Wrapping? Suturing required?Suturing required? Allergenic?Allergenic?

CuraMedical recommendations? Surgery ↓ GelatineOCCollagen DentalYesNoNo ENTYesNoNo Vascular anastomosis NoYesNo CardiacNoYesYes NeurosurgeryYes No (pH) No (swelling) VisceralYesYesNo ReconstructivePossiblePossibleYes OrthopaedicYes No (pH) Yes