BloodSTOP® and BloodSTOP® iX are biocompatible, non-irritating, woven matrices of fibers made from natural plant compounds. They adhere to a wound, initiate blood coagulation, stop bleeding, and form a protective layer to create an optimal environment for wound healing. Their water solubility allows for removal by rinsing, without disruption of a clotted surface.
These products are covered by U.S. Patent No. 7,262,181.
Questions About BloodSTOP Hemostatic Gauze Products
Q: I have used your wonderful product to achieve hemostasis during and after dental surgeries. I would like to know if it is completely resorbable (dissolvable). Is it safe to place it inside an extraction socket and close the wound completely inside tissues using sutures?
A: BloodSTOP materials, when coming in contact with blood, initiate immediate coagulation and achieve hemostasis. They then dissolve into a gel that is completely water soluble, and does not have to be removed, i.e. because it will be washed out by saliva and/or wound exudates over a short period of time. Many of the standard techniques include packing the socket and adapting or not adapting the wound with suture(s), leaving space for drainage. We cannot recommend the creation of a closed contaminated space, as that would increase the risk for abscess formation.
Q: Can BloodSTOP be used on a facelift? For the most part it would be used on the incision line but can it be put in the flap and sutured over?
A: The indication for our BloodSTOP iX FDA 510(k) clearance is: Emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required.
Topical hemostatic agents are used when surgical hemostasis is inadequate or impractical.
Cosmetic surgeries are elective procedures and the candidates are usually not anticoagulated.
A surgeon would use a hemostat on an incision line only when he/she encounters a situation where blotting off, compression, electrocauterization or ligation would not be sufficient or cause unnecessary damage.
LifesciencePLUS has no human studies on how much BloodSTOP iX material can safely be used in this situation and whether any possibly remaining gel would interfere with the accurate adaptation of the skin surfaces during the closure of such cosmetically critical cuts.
Inaccurate wound edge adaptation and any material remaining in between could possibly interfere with healing and lead to increased scar and keloid formation.
As you already correctly allude to, these are, for the most part, not operations that take place within a normally sterile body cavity and BloodSTOP iX should not be put under a flap and sutured in. With any contamination, this could increase the risk for infection.
BloodSTOP iX can be used topically for any blood-oozing or openly bleeding, external, non-infected suture lines when other corrective measures were insufficient, or not indicated.
Apply BlodSTOP iX and cover with a transparent dressing to keep BloodSTOP iX moist. Leave on for no more than 24 hours. Carefully remove transparent dressing. To remove excess BloodSTOP iX material, rinse with sterile saline and wipe gently.
Q: Has BloodSTOP® been clinically tested?
A: The BloodSTOP family of hemostatic products has undergone extensive laboratory testing to ensure safety and efficacy for intended uses. In markets outside the US, BloodSTOP iX has a ten-year history of safe and effective clinical use in internal wound care to stop bleeding fast.
Q: What are the similarities between BloodSTOP® and BloodSTOP® iX products?
A: Both types are composed of etherized, oxidized, regenerated natural cellulose, and both have demonstrated faster time-to-hemostasis than is possible using traditional wound care methods.
Q: What are the differences between BloodSTOP and BloodSTOP iX products?
A: BloodSTOP is for surface wound care and is proven fast-acting, safe and effective to stop bleeding from cuts, abrasions, bites and punctures to the skin surface. BloodSTOP iX is a finer-grade, purified hemostat that it is 100% water-soluble, biorebsorbable, and passes the more rigorous biocompatibility tests required for use inside the body: hemocompatibility, intracutaneous reactivity, subcutaneous implantation, genotoxicity, and chronic toxicity. It is double-packaged for sterile delivery.
Q: Are BloodSTOP products absorbable?
A: BloodSTOP iX is a Class III, CE Mark Certified product, approved in Europe for use in internal surgical procedures. The material itself is proven to hydrolyze and be absorbed by the body over time with no evidence of any residuals after 4-6 weeks. It is completely water soluble and inert.
Q: Can BloodSTOP iX be left in the body?
A: BloodSTOP iX is designed to be left in place and not removed. However, as with all absorbable hemostats, it is recommended that any excess material be removed as a precaution. It is best to fully hydrate BloodSTOP iX prior to closure in order to stimulate absorption.
Q: Are BloodSTOP and BloodSTOP iX irritating?
A: BloodSTOP and BloodSTOP iX are non-irritating, biocompatible and pH neutral.
Q: What is the cost of BloodSTOP and BloodSTOP iX relative to other comparable products on the market?
A: BloodSTOP and BloodSTOP iX have a significantly lower cost than other existing products, such as Johnson & Johnson’s Surgicel and Gelfoam products, collagen products, and human or animal thrombin products.
Q: Are there any known side effects for BloodSTOP products used in approved wound care applications?
A: In the ten-year history since BloodSTOP technology was introduced, there have been no reported or observed side effects. In animal tests, BloodSTOP and BloodSTOP iX have demonstrated effectiveness in hemostasis without causing irritation, heat, inflammation, or redness.
Q: Will the clotted surface be disturbed or pull away from the wound site when I remove the product?
A: Not when removed properly. BloodSTOP should be gently rinsed away with sterile water or saline solution without disturbing the wound.
Q: How does BloodSTOP work?
A: When applied to a wound, BloodSTOP products quickly absorb blood and exudates, transform into a gel to seal the wound with a protective transparent layer, bind and activate platelets, provide support for clot formation, and create an environment for wound healing.
Q: How long can BloodSTOP products be stored after purchase?
A: BloodSTOP products come individually packaged in sealed, sterile pouches and have a shelf-life of approximately five years when properly stored.
Q: How are BloodSTOP products sterilized?
A: With gamma radiation, in compliance with international standards for medical device sterilization.
Q: Will I need to apply pressure to the site after the BloodSTOP has been applied and, if so, for how long?
A: For both internal and surface wounds, additional layers of the product and pressure can be applied according to the nature and intensity of the hemorrhage to be stopped. For internal applications, pressure should be applied over BloodSTOP iX with a wet piece of cotton gauze for approximately one minute. See package insert for complete instructions.
Q: How do I remove BloodSTOP once the bleeding has stopped?
A: To remove excess BloodSTOP material on surface wounds, simply rinse away with sterile water or saline solution, wiping gently if necessary. When used internally, excess material should be flushed with sterile water or saline solution before surgical closure.
Q: Where can BloodSTOP® be used?
A: BloodSTOP can be used on any skin surface cut, scrape, or razor nick, and inside nostrils in the case of nosebleeds.
Q: What is the cost of BloodSTOP relative to other comparable products on the market?
A: BloodSTOP is a fraction of the cost of comparable hemostatic products, but with more added value in terms of safe, fast-acting and non-irritating wound care for people of all ages.
Q: Do I need doctor’s prescription when I order it?
A: NO. Over-the-counter BloodSTOP is available through the LifeScience PLUS website, at certain drugstore retailers, and for volume purchases through distributors worldwide.
Q: Are there any known side effects?
A: In the product’s ten-year history, there have been no reported or observed side effects. In animal tests, BloodSTOP has been demonstrated to stop bleeding in one minute or less, with no irritation, heat, inflammation, or redness.
Q: Who can use BloodSTOP?
A: BloodSTOP products can be used for or by anyone with surface wounds who is bleeding —whether a minor cut or a major injury. It is safe for all ages. It is commonly used in a wide variety of settings—at home and school, at sporting events, and in intervention by first responders. In serious emergency situations, a medical professional should always be consulted.
Q: How does it work?
A: When applied to a wound, BloodSTOP quickly absorbs blood and other body fluids, transforms into a gel to seal the wound with a protective transparent layer, actively aids in stopping bleeding, and creates an environment for wound healing.
Q: How long should I leave BloodSTOP on before it needs to be removed?
A: It can be left on as long as necessary to stop bleeding. When the bleeding has stopped, BloodSTOP can be removed from surface wounds by rinsing with sterile water or saline solution and gentle wiping so as not to disturb the wound.
Q: Can I use BloodSTOP on my pets?
A: Yes, BloodSTOP is safe and effective in veterinary applications and therefore, on all animal surface wounds. For serious wounds, a veterinary professional should be consulted.
Q: Should I cover BloodSTOP with an additional dressing after it has been applied?
A: Usually not. But, if desired, an additional standard dressing may be used.
Q: Will I need to apply pressure to the site after the BloodSTOP has been applied?
A: Applying pressure will assist in hemostasis. However, it will not always be necessary for small cuts or injuries. For serious wounds, a medical professional should be consulted.
Q: If I cut the BloodSTOP into smaller pieces, can I keep the unused portion and use it at a later time?
A: Once the sterile package has been opened, and the contents handled, it renders the material non-sterile and unfit for reuse.