Frequently Asked Qustions
VETIGEL® is a flowable haemostatic gel comprised of algae- and fungi-derived biopolymers. Its components are sodium alginate, poly {N-acetyl-D-glucosamine, D-glucosamine) and water.
VETIGEL® is a haemostatic gel that immediately stops bleeding via mechanical action, without the need for applied pressure. Gel that comes directly in contact with blood ionically crosslinks, forming a strong mechanical barrier that maintains durable and long-term haemostasis at the wound site. VETIGEL® allows the patient to rapidly produce their own stable endogenous fibrin patch at the wound site. VETIGEL® can be easily removed without disturbing the fibrin patch thanks to its flowable, non-porous nature.
VETIGEL® is applied by following five steps:
- Prime the syringe
- Use gauze to remove excess blood from the field
- Perpendicularly administer gel, directly to the wound
- Shear the gel against the tissue while pulling the syringe away from the wound
- {Optional) Apply gentle but firm pressure with a sterile wetted gauze atop the gel
VETIGEL® is absorbable, and is intended to absorb within weeks of application, while minor residuals may take longer to absorb.
VETIGEL® is a plant-based biopolymer solution made of sodium alginate, poly {N-acetyl-D-glucosamine, D-glucosamine)and water. Given VETIGEL® is a hydrogel mainly comprised of water, the significant majority of the product is absorbed within weeks. The residual poly {N-acetyl-D-glucosamine, D glucosamine) is expected to degrade in the body enzymatically, and alginates traditionally degrade via acid hydrolysis and/or dissolving due to ion exchange. VETIGEL® has been subjected to human-grade ISO 10993 biocompatibility testing, including long-term implantation studies that have shown the material does not present long-term risk to the patient.
VETIGEL®’s material characteristics make it easy to remove if a clinician chooses to. Removal of excess material is recommended, but it is at the clinician’s discretion as to whether they would like to fully remove the material. In more severe cases, removal may result in re-bleeding.
To remove, it is recommended to use either a sterile swab or saline and lavage to gently unseat the material and leave behind a durable clot. These methods are particularly recommended in scenarios where post-operative drainage may occur {i.e. enucleations, epistaxis).
With correct technique, VETIGEL® stops bleeding in seconds. The gel’s combined adhesiveness to a variety of tissue types and cohesive strength allow for the gel to be applied effectively without the need for additional pressure.
To remove, it is recommended to use either a sterile swab or saline and lavage to gently unseat the material and leave behind a durable clot. These methods are particularly recommended in scenarios where post-operative drainage may occur {i.e. enucleations, epistaxis).
In companion animals, VETIGEL® has been used to stop moderate to severe bleeding in many clinical cases. Depending on the pressure of bleeding and size of wound, clinicians may opt to use multiple applications in heavy arterial bleedingscenarios. Proper use of VETIGEL® as an adjunctive haemostat is not a replacement for effective surgical technique.
Yes, VETIGEL® works with or without applied pressure. In cases where applied pressure is desired, apply VETIGEL® and apply gentle but firm pressure with a sterile wetted gauze atop the material. This may be attempted more than once if preferred or if the bleeding source is difficult to visualize.
Yes, VETIGEL® can be layered and used with optional manual compression in order to ensure effective haemostasis is achieved.
No, VETIGEL® does not elicit an exothermic reaction.
Yes. VETIGEL® is terminally sterilised via gamma irradiation.
VETIGEL® Precision Accessories are sterilised by gamma irradiation. Clinicians may reuse accessories at their owndiscretion, but they must be cleaned and autoclaved first. VETIGEL® Precision Accessories should not be autoclaved at temperatures exceeding 12O°C.
VETIGEL® was assessed for its biocompatibility per ISO 10993 (human medical device biocompatibility standards} that was interpreted for veterinary use. This testing included cytotoxicity, intracutaneous reactivity, maximisation sensitisation, pyrogenicity, genotoxicity, and more. The results of the testing confirmed that VETIGEL® is biocompatible and give assurance that VETIGEL® does not pose risk of rejection by the body.
VETIGEL® is comprised of sodium alginate dissolved in water with solid particles of poly (N-acetyl-D glucosamine, D-glucosamine) dispersed in it. In two limited studies, use of VETIGEL® was not shown to result in a clinically significant increase in adhesion formation as compared to other methods. While granular materials may be known to increase risk of adhesions, alginates are known to have well established anti-adhesion properties.
VETIGEL® is labeled as a single-use sterile device and cannot be re-used.
VETIGEL®’s mechanism of action is mechanical and occurs independently of the patient’s clotting process. VETIGEL® creates a strong, adhesive mechanical barrier at the wound site that will maintain haemostatic effect while it remains in contact with the wound. VETIGEL® is recommended to be left in place in patients with coagulopathy as there may not be a strong endogenous clot.
Yes, VETIGEL® can be applied topically.
VETIGEL® has been used in craniotomies, laminectomies, and other cerebrospinal procedures. It is recommended to fully remove all material post-treatment. Best practices are to remove all foreign material, including VETIGEL®, incerebrospinal procedures.
VETIGEL® can be used in epistaxis procedures and/or intranasally. Removal of excess is recommended to ensure driedVETIGEL® does not block or irritate the sinuses.
VETIGEL®’s gel form lends itself to easily flowability and conformance to complex wound geometries. Due to its ionic crosslinking nature in the presence of blood, VETIGEL ® has been observed forming a plasticised, strong matrix at the bleeding sites, which may reduce or eliminate the risk of fragmentation. This functionality was designed into the product to improve upon many existing products (sponges, powders) that may present this risk. The risk of an embolic event after administering VETIGEL ® has not been formally evaluated in a clinical setting.
Sodium alginate is a widely used biopolymer in wound dressings intended to keep wounds moist and to promote wound healing. Poly (N-acetyl-D-glucosamine, D-glucosamine) is often used as an antimicrobial agent in medical devices. These materials have been used in ISO 10993 biocompatibility studies and in clinical scenarios where there have been no reports of increased infection. As it is non-porous, VETIGEL™ has a low risk of serving as a nidus of infection. However, the risk of increased infection after administering VETIGEL® has not been formally evaluated in a clinical setting. Use standard practices when applying VETIGEL® in contaminated areas.
VETIGEL® has no known or expected interactions with drugs. Clinical scenarios where there have been no reports of increased infection. As it is non-porous, VETIGEL® has a low risk of serving as a nidus of infection. However, the risk of increased infection after administering VETIGEL ® has not been formally evaluated in a clinical setting. Use standard practices when applying VETIGEL ® in contaminated areas.
VETIGEL® is not intended to be ingested, but in the event of accidental ingestion, the constituent polymers are. Generally Recognised as Safe (GRaS) and pose no known risk. Clinical scenarios where there have been no reports of increased infection. As it is non-porous, VETIGEL® has a low risk of serving as a nidus of infection. However, the risk of increased infection after administering VETIGEL® has not been formally evaluated in a clinical setting. Use standard practices when applying VETIGEL ® in contaminated areas.
CONTRAINDICATIONS
- The safety and effectiveness of VETIGEL ® for use in ophthalmic procedures have not been
- VETIGEL® is not intended to be used as a wound-closure
WARNINGS
- Do not inject VETIGEL® intravascularly due to risk of clinical scenarios where there have been no reports of increased infection. As it is non-porous, VETIGEL has a low risk of serving as a nidus of infection. However, the risk of increased infection after administering VETIGEL® has not been formally evaluated in a clinical setting. Use standard practices when applying VETIGEL® in contaminated areas.
VETIGEL® should be stored dry and maintained between 2-25°C upon receipt. VETIGEL® should not be stored in direct sunlight. Studies are ongoing to extend VETIGEL®’s shelf-life beyond 24 months.
VETIGEL® can be used on a variety of procedures, including but not limited to:
Dental extractions, oral mass removals, abdominal and thoracic mass removals, soft organ biopsies, enucleations, spays & neuters, amputations, venous & arterial bleeds, epistaxis, cholecystectomies, catheterisation, lacerations, laminectomies/hemi-laminectomies, and ear & tail lacerations.