AXIOSTAT – Haemostatic Dressing

What is Axiostat®? Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control moderate to profuse bleeding within minutes of an application by providing an active mechanical barrier to the wound site. Axiostat® stops moderate to severe bleeding due to cuts, abrasions, lacerations, venous/arterial punctures, surgical bleeding and more. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the bleeding site. What are the advantages of using Axiostat®? Axiostat® is ready to use and can be cut to suit different wound sizes. They can be delivered through a pool of blood and is simple to apply and remove by a non-medical first responder. Axiostat® also stops bleeding faster than any available haemostat. It does not have any side effects such as viral transmission (associated with Gelatin, Collagen products) or exothermic reaction (association with Kaolin/Zeolite products). How easy is it to use Axiostat®? Axiostat® comes in sterile multi-layered moisture barrier pouches which can be easily opened using one hand. Axiostat® can be directly applied to the bleeding site with palm pressure. It doesn’t require pre-mixing or preparation prior to use. Can Axiostat® be cut or folded prior to use? Yes. Axiostat® can be cut into multiple pieces and used on various injuries. It can also be folded and packed into actively bleeding wounds. How easy is it to remove Axiostat®? In case the foam is pulled out without irrigating saline will it be painful & what will happen? Axiostat® can be removed using saline or water irrigation. It will turn into a gel that can be easily peeled away without causing any trauma to the wound. This is one major advantage in using Axiostat® as it can be completely removed from wound without dislodging the already formed clot. Does one need prior training to use Axiostat®? No. Axiostat® usage is visually represented on the pack and can be easily understood by a lay-man through minimal demonstration of usage. What are the precautions that you need to take care while using Axiostat®? Axiostat® has a higher affinity to blood and may stick to hands if not dry. Axiostat® also needs adequate blood to wet the contact surface and this aids in quick control of bleeding. What are the available variants of Axiostat®? Axiostat® Surgical: L88 – 8x8cm | M85 – 8x5cm | S55 – 5x5cm | V55 – 5x5cm Axiostat® Vascular: V55 – 5x5cm | V35 – 3.5×3.5cm Axiostat® Military: MIL88 – 8x8cm Axiostat® Haemodialysis: N22 – 2x2cm Axiostat® Emergency: L88 – 8x8cm | M85 – 8x5cm | S55 – 5x5cm | N14 – 1x4cm | N18 – 1x8cm Axiostat® Dental: D11 – 1x1cm | N22 – 2x2cm | N14 – 1x4cm | V35 – 3.5×3.5cm Can the patient be taken for X-ray after application of Axiostat®? Yes. Axiostat® is X-ray compatible and provides good support to the bleeding site and facilitates easy & quick X-ray procedure. Is Secondary dressing needed after using Axiostat®? Secondary dressing such as cotton gauze may be used to keep Axiostat® dry and in position. Axiostat® sticks to bleeding wound quickly and it eliminates the need for any other dressings. Is Axiostat® absorbable in the body? No. Axiostat® is a non-absorbable dressing and is not an Implant. It should be removed prior to wound closure using water/saline. Is it allergic? There have been no known reported allergic reactions from the use of Axiostat® since 2011. Chitosan used in Axiostat® does not contain any protein or allergic components. How long can Axiostat® be kept on the wound after application? Axiostat® can be kept on wound up to 24 hours although bleeding is expected to have stopped after a few minutes. What is Axiostat® made of? Axiostat® is made of a naturally occurring polymer known as Chitosan (Poly [β-(1,4)-2-amino- 2-deoxy- D- glucosamine],) which is a biocompatible polysaccharide extracted from shellfish. They are rigorously processed and purified prior to fabricating into the dressing and is terminally sterilized using Gamma irradiation. What if the wound is larger than the Axiostat®? Axiostat® comes in various sizes suitable to cover standard wounds. In case wounds are larger or there is an extended laceration, multiple Axiostats can be applied side by side. We also provide custom Axiostat® size on large orders pertaining to a particular indication What is the regulatory status of Axiostat® ? Axiostat® has been approved by USFDA 510(K), CE marked and also approved in 25+ countries. Axiostat® is manufactured in ISO 13485 and GMP certified facility. Which variant is applicable for what purpose? Axiostat® Surgical: All ectomy cases, General surgery Axiostat® Vascular: Interventional Radiology Procedures, Interventional Cardiology Procedures(Femoral & Radial) Axiostat® Military: Gunshot wounds, Puncture or stab wounds Axiostat® Others: CVC procedure, Haemodialysis, Head & Neck Trauma, Arterial bleeding, Maxillofacial trauma, Oral surgeries How Axiostat® is different from other surgical haemostats? Surgical haemostats are designed to control oozing bleeding during surgical procedures and they are resorbed in the body within 7 days. Surgical haemostats based on Gelatin, Collagen, Oxidised cellulose, Thrombin etc are incapable of controlling flowing bleeding and thus cannot be effectively used to control external trauma bleeding. Axiostat® works on the principle of controlling bleeding through strong adhesion independent of clotting mechanism and all surgical haemostats work on the basis of absorption and activation of the clotting cascade. Has there been any clinical study conducted on the safety and efficacy of Axiostat®? Indian Journal of Emergency Medicine International Journal of Toxicology – Mechanism and methods International Journal of Oral Health and Medical Research Journal of Contemporary Dental Practice Can it be substituted for Sutures? Axiostat® is not a substitute for wound closure devices such as sutures. Axiostat® provides instant temporary control of bleeding and helps the wound dry prior to suturing or any other surgical procedure Can it be used for internal bleeding? Yes. However, Axiostat® is a non-absorbable dressing which is not to be used as an implant. Axiostat® should be removed prior to closing the wound within 24 hours. Is there a benefit to using Axiostat® in my Angio procedures through the femoral artery? Absolutely! Using Axiostat® achieves haemostasis in under 3-5 minutes. Conventional methods of gauze & compression requires upto 30 minutes of continuous pressure application to stop the bleeding. Axiostat® also reduces the chances of rebleeding to a great extent. What are the Warnings and Precautions for Axiostat®? Axiostat® is a non-absorbable dressing. Do not implant. It is sterile and for single use only. Do not use Axiostat® over eyes. Will Axiostat® work on patients with bleeding disorders or who are on blood thinning drugs ? Axiostat® works independently of the natural clotting mechanism and is based on an adhesive property due to charge density of blood components.

For more information on AXIOSTAT – Haemostatic Dressing talk to Wessex Medical Ltd