CuraMedical

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

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• The Absorbable Haemostat Family

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

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

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

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• Absorbable haemostatic agents

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• An absorbable haemostatic agent, surgical is
• (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
• 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

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

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Technical data Technical data Technical data Technical data
Gelatine OC Collagen
Origin Animal Vegetal Animal
Produced from Porcine Rayon or cotton Bovine Porcine Equine
Extracted from Pig skin Wood pulp Cotton Skin (bovine or porcine Achilles tendon (bovine or equine)
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How do haemostats agents provide haemostasis? How do haemostats agents provide haemostasis? How do haemostats agents provide haemostasis? How do haemostats agents provide haemostasis?
Gelatine OC Collagen
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
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To what extent are haemostats absorbent? To what extent are haemostats absorbent? To what extent are haemostats absorbent? To what extent are haemostats absorbent?
Gelatine OC Collagen
Absorbency in times of its own weight 45 50 5 10 75 80
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Are all haemostats absorbable? Are all haemostats absorbable? Are all haemostats absorbable? Are all haemostats absorbable?
Gelatine OC Collagen
Absorption time 4 6 weeks 1 2 weeks 5 8 weeks
Absorption conditions Always absorbable Absorption only possible when saturated with blood! Always absorbable
Remark 3 days when in contact with mucous tissue
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Are all haemostats safe? Are all haemostats safe? Are all haemostats safe? Are all haemostats safe?
Gelatine OC Collagen
General Carefully read the instructions for use Carefully read the instructions for use Carefully read the instructions for use
(Over) packing Packing material to fill cavities Never Never
Excess quantity Remove Remove Remove
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Are all haemostats safe? Are all haemostats safe? Are all haemostats safe? Are all haemostats safe?
Gelatine OC Collagen
pH Neutral Acid (pH lt 3) Slightly Acid
Swelling Back to original form after liquid absorbance Swelling can cause (undesired) pressure Swelling can cause (undesired) pressure
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Secondary effects? Secondary effects? Secondary effects? Secondary effects?
Gelatine OC Collagen
Secondary effects Risk of tissue fibrosis Interference with callus formation Bovine collagen allergy
Secondary effects Interference with epithelialisation Decreases bonding effect of cement
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Contraindications? Contraindications? Contraindications? Contraindications?
Gelatine OC Collagen
Infected tissue Do not use Do not use 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
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Are haemostats to be removed? Are haemostats to be removed? Are haemostats to be removed? Are haemostats to be removed?
Gelatine OC Collagen
Removal after haemostasis is achieved Only if over packing Packing and over packing and nearly in all indications Only if packing and over packing
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Physical remarks? Physical remarks? Physical remarks? Physical remarks?
Gelatine OC Collagen
Suturing No Possible No
Wrapping No Yes No
Sticking No No Yes
Swelling No (only to its original form) Yes Yes
Apply Dry, wet or impregnated Dry Dry or wet
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Are all Haemostats compatible with drugs? Are all Haemostats compatible with drugs? Are all Haemostats compatible with drugs? Are all Haemostats compatible with drugs?
Compatibility? Gelatine OC Collagen
Drugs Yes No Some antibiotics
Thrombin Yes No Possible
Biological sealants (glues) Yes No No
Synthetic sealants (glues) Yes No No
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• Criteria to choose a haemostatic agent
• Duration to obtain haemostasis?
• Swelling?
• Absorbency?
• Duration and conditions of absorption?
• Wrapping?
• Suturing required?
• Allergenic?

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CuraMedical recommendations? CuraMedical recommendations? CuraMedical recommendations? CuraMedical recommendations?
Surgery ? Gelatine OC Collagen
Dental Yes No No
ENT Yes No No
Vascular anastomosis No Yes No
Cardiac No Yes Yes
Neurosurgery Yes No (pH) No (swelling)
Visceral Yes Yes No
Reconstructive Possible Possible Yes
Orthopaedic Yes No (pH) Yes