Hemostasis by axiostat (protonated chitosan )

1. Hemostasis wound care by
Axiostat
Shadi Albaik
Clinical manager at Kaizmed

2. Wound
Management

3. Objective
Wound Care introduction
Chitosan
Maxiocel
Case study
Axiostate
Case Study

4. Axio is a manufactural focused on Advanced Surgical, Trauma and
Wound Care.
• Made in India
• AXIOSTAT (a patented, FDA 510k and CE approved medical device made from 100%
Chitosan)
• MaxioCel (a chitosan microfiber dressing for Diabetic foot ulcers and other chronic
ulcers)

5. Wounds
A wound is an injury to living tissue caused by a cut, blow, or other
impact .

6. Types of wounds
Acute Wound
• Follows the normal stages of wound healing to
achieve complete repair. Such as:
• Incisions and excisions
• Abrasions
• Puncture wounds
• Penetration wounds
Chronic Wound
• The process of repair continues on for greater than
30 days

7. Wound Management
Is a treatment of the wound, by providing appropriate environment for the
wound
1- Stop bleeding
2- Protection from infection
3- Absorb exudate – to soak up blood, plasma, and other fluids.
4- Ease pain.
5- Remove foreign objects from the wound to speed up the
healing;
6- Reduce psychological stress
Using Wound dressing

8. Wound healing stages:
Wound healing is a physiologic process in which the skin or organ or tissue repairs itself after injury.
- Skin healing goes through 4 phases in order as follow:

11. Why it is important to stop bleeding instantly
• 40 ml/min of blood loss continuing for 20 minutes is fatal
• Around the world, almost 16,000 people die everyday from all types of
injuries.
• 11 people die every minute of every day. Major causes are road
accidents, industrial accidents, combat, falls and violence.
• Failure to start appropriate early management in bleeding trauma
patients is a leading cause of preventable death from trauma
1. Short time
2. Reduce amount of bleeding

12. Class I Hemorrhage
•15% of total blood volume
•no change in vital signs
Class II Hemorrhage
•15-30% of total blood volume
•tachycardic (rapid heart beat)
Class III Hemorrhage
•30-40% of total blood volume
•blood pressure drops, the heart rate increases
Class IV Hemorrhage
•40% of total blood volume
•Body cannot compensate, aggressive resuscitation
required
TYPES OF BLEEDING

13. Wound care goals:
• Identify patient’s wound and wound complications
• prescribe preventive measures to promote skin integrity
• to treat wound problems once they develop.
Wound care is the key for achieving the best result, patient
satisfaction and healing downtime.

14. Wound Dressing
• Key purposes of a dressing are:
1- Stop bleeding
2- Protection from infection
3- Absorb exudate – to soak up blood, plasma, and other
fluids.
4- Ease pain.
5- Remove foreign objects from the wound to speed up the
healing;
6- Reduce psychological stress
is a sterile pad applied to a wound to promote healing and protect
the wound from further harm. dressing is designed to be in direct
contact with the wound.

15. Wound Dressing
Bleeding
Control
Wound Care
Chronic wound

16. CHITOSAN

17. CHITOSAN PRODUCTION
Animal origin Non-animal origin
Exo/Endoskeleton of shellfish Chitin
Demineralization
2-5% HCl 5% NaOH
Deproteination
NH-COCH3
Chitin
NH-COCH3
NH2
Chitosan
NH2
Deacetylation
Boiling
40-50% NaOH pH <6.5
+
NH3
Protonated Chitosan
+
NH3

19. What is Chitosan?
The newest technology with best outcomes.
 Chitosan: sugar that is obtained from the hard
outer skeleton of shellfish including oysters,
shrimp and crab.

21. Chitosan is a positively charged, natural polymer that actively reacts with negatively charged
blood to create a very strong barrier that stops bleeding instantly
What is Chitosan
Human body negatively charged
Natural Chitosan
Bleeding stopped

23. Chitosan is a natural polymer , positively charged, that actively reacts with negatively charged
blood to create a very strong barrier that stops bleeding instantly
PROPERTIES
• Polycationic
• Mucoadhesive
• Anti-microbial
• Non-toxic
• Biodegradable
• Biocompatible
Why Chitosan

25. Introducing Axiostat
▪ 100% Chitosan Haemostatic Dressing
▪ FDA, CE Certified
▪ Designed to control severe arterial
bleeding within minutes of application
▪ Can stop bleeding due to lacerations,
ruptures and abrasions
▪ Ready to use and can be cut to suit
different wound sizes
▪ Hypoallergenic no known side
effect
▪ Active on all sides
Axiostat® is a sterile, single use haemostatic dressing intended to be
used for temporary control of bleeding wounds.

26. How Axiostat works
The working of Axiostat can
be explained in 5 steps
1. Compression
2. Charge Based Adhesion
3. Plasma Sorption
4. Platelet Activation
5. Plug Formation
Axiostat works on a principle of axio clotting technology.

27. How Axiostat works

29. Mechanism of Action
• Through its positive charge, the PBT biopolymer attracts red blood cells (RBC) and
platelets and entraps them into its porous structure,
• which leads to the activation of the platelets and results in formation of a strong
blood clot.
• The combined effect of bio-adhesion and strong blood clot is instant hemostasis.
• This method of bleeding control is robust enough that it works irrespective of the
natural clotting factors, hence PBT is successful even in patients taking the blood
thinning medications
• Lastly the enhanced cationic charge provided by the PBT biopolymer also
provides strong anti-microbial properties to the material and restricts entry of
external bacteria into the wound site.

31. Why Axiostat is superior to conventional dressings
▪ High fluid absorption capacity: 40x by
weight
▪ Quick haemostasis: 3-5 min
▪ Non-exothermic: Gentle on injured
site
▪ Stable even after fluid absorption:
Easy removal
▪ No leeching into tissue
▪ Pliable structure: Easily conforms to
any wound shape, size

32. Axiostat Surgery
• BLEEDING AS A COMPLICATION DURING SURGICAL PROCEDURES-
• Conventional techniques takes longer time to achieve haemostasis.
• Patients on anti-coagulant takes longer time to achieve hemostasis
• Pre-mixing and preparation of haemostatic agent before application
• Excessive bleeding may lead to IV fluid or blood transfusion
• May involve medical risks like deep vein thrombosis and pulmonary embolism
• Risk of infection

33. Axiostat
Control
Bleeding
Protonated chitosan Technology

34. Protonated Polymer Technology

35. CHITOSAN
•Polysaccharide (likecellulose orstarch)
•Co-polymer ofglucosamine and N-acetyl-glucosamine
•Obtainedbydeacetylationof chitin
•Second most abundantnaturalbiopolymerafter

36. How is the material made ?

37. Potonated Polymer Technology

38. Developed of chitosan
1.this protonation is pH-dependent, at a pH above 6.5 chitosan
undergoes neutralization and loses the positive charge at the
physiological pH of 7.4.
Researchers have developed numerous chemical derivatives
of chitosan to improve its cationic properties at physiological
conditions
such chemical modifications often lead to other drawbacks
such as inconsistency, increased processing costs, risk of
toxicity, and reduction in chitosan’s molecular weight
Finally, we formulated chitosan with the (PBT), which only
relies on the physical properties and microscopic morphology
of this natural material to maximize its cationic charge.

39. Result After Modification of Chitosan
Axio is able to maintain its positive charge and provide strong mucoadhesion
even under physiological conditions.
Another advantage of PBT is the faster hemostasis due to electrostatic
interaction between positively charged biopolymer and the negatively
charged blood cells.

43. Time to clot and strength of clot

44. PREVENT
rebleeding Swelling
Skin irritation Vascular complication
No allergy after removal
of axiostat
Furthere there was no
incidence of device
related bleeing
complication during 5
days after the surgery.

45. Stop Bleeding
Positive
charge (+)
Compression
at the wound
site
Stimulate
collagen
Short time
(immediately)

46. No Need for secondary dressing
Mucoadhesive
•Contain
Starch
•No leeching
into tissue
Gentle on
injured site
•Easy to
remove

47. Hypoallergenic no known side effect
•100% Natural –
chitosan
No Allergy No Infection
biocompatibility
and
biodegradability

48. can be formulated depend on wound
Can be cutted Microfibre Without plaster
Use with
different wound
shape and size

49. Reduce infection rate
Complete sealing
▪High fluid
absorption
capacity 40x by
weight
To avoid leakage
Stable even after
fluid absorption

50. Reduce pain
•By blocking
Brady-kinase
Block Pain
circulation
Pain reduced

51. Sterilized by Gamma radiation
•To avoid disturb
the positive charge
Stable with
technology

53. Variants Brand Name Indications
Emergency/Surgical S55 M85
L88
Scalp, Head and Neck trauma ,
Lacerations and deep cuts, minor
surgeries (EMERGENCY IF available
)
Suture anastomosis, Nephroctomy
,CTVS, Post resection tumor
bleeding
Vascular V55
V35
Femoral arterial bleeding
Radial arterial bleeding
Military MIL88 Gunshot wounds, Shrapnel
punctures , deep stab wounds ,IED
Blasts
Hemodialysis N22 N14
N18
Hemodialysis
Maxillofacial Operation
Epistaxis bleeding
Commando Surgery
Dental D11 Patient on Blood thinners ,Tooth
Axiostat Variants

54. SIZES
5
cm
5 cm
8 cm
5
cm
Composition Chitosan - 100%
Material Natural, Biocompatible, Positively charged polymer
Type
Highly absorbent sponge
(absorbs minimum 30x its weight)
Sterility Sterilized using Gamma irradiation
Use Single-use
Flexibility
Pliable, conformable to any wound shape,
active on all sides
8 cm
8
cm
L88: 8cm X 8cm
M85: 8cm X 5cm
S55: 5cm X 5cm
V55: 5cm X 5cm
www.axiobio.com

55. S55
5 cm X 5 cm
Emergency Variants
M85
8 cm X 5 cm
L88
8 cm X 8 cm
• Head & Neck Trauma
• Arterial Bleeding

56. V35
3.5 cm X 3.5 cm
Vascular Variants
V55
5 cm X 5 cm
thickness 1 cm

57. Apply and remove

58. www.axiobio.com
HOW TO USE Axiostat
®
Peel off the pouch and
Take Axiostat
Apply Axiostat on the
entire site of bleeding
with mild compression
for 3-5 min
Once applied, do not lift
or remove Axiostat, not
even to check
haemostasis
To remove, irrigate with
saline and gently
peel it off.
Do not implant

64. • to how to use axiostat (apply and remove it) , kindly find below steps:
•
1. Open a package and remove Axiostat from it under sterile technique.
2. Place it on the bleeding wound.
3. Apply Axiostat Above the puncture with 3 finger Technique on central of Axiostat sponge until Axiostat
sticks onto it.
4. Continue pressure on it at least 3 minutes or until axiostat sticks onto it.
5. Lift Finger once Axiostat stick on the site.
• Note : (Once Applied, do not lift, or remove Axiostat, not even to check hemostasis )
1. To remove Axiostat, irrigated with ample amount of normal saline and gently removed post achievement of
hemostasis.

65. Result
Ease of application
Ease of removal
Adherence to wound
Conformability of dressing to
wound

68. Market
Inside
Hospital
Operation Vascular
Dental Hemodialysis
E.R trauma
case
Paramedic
Outside
hospital
Dental Health Clinic
Pharmacy Factories
Schools Military

69. Vascular Bleeding

71. CATH. LAB.

73. Axiostat Vascular Training Video
To be used in Variant
Femoral access
sheath removal
V55
Radial access
sheath removal
V35
CAUTION
Do not use other Axiostat Variants (Emergency etc) to stop bleeding in Cath Labs (for
Interventional Cardiology) as they may require additional compression and hence haemostasis
times may change drastically.

75. Compression & Removal - Axiostat Vascular

78. CASE STUDY
BLEEDING DUE TO OPEN INGUINAL
HERNIA REPAIR
Haemostasis achieved
with Axiostat
Application of Axiostat
at the hernia repair site

79. CASE STUDY
BLEEDING DUE TO OPEN INGUINAL HERNIA REPA
Location: ESIC hospital, Ahmedabad-India
Haemostasis achieved
with Axiostat
Application of Axiostat
at the hernia repair site
www.axiobio.com

80. Military

86. Nasal
bleeding

87. Nasal
axiostat

90. Factories

91. Health clinic

92. Pharmacy