FDA-Cleared Hemostatic Device
TRAUMAGEL
A fast-acting hemostatic gel that controls moderate-to-severe external bleeding — no preparation, deployed instantly.
TRAUMAGEL® is a single-use, hemostatic gel for temporary external use, indicated for controlling moderate to severe bleeding. Supplied as an individually pouched, pre-filled 30 mL syringe, it is the only flowable hemostatic device cleared for use in moderate-to-severe external bleeding — requiring no preparation and deployable instantly.
TRAUMAGEL® is comprised of a proprietary blend of polyanionic and polycationic polysaccharides — sodium alginate and poly (N-acetyl-D-glucosamine, D-glucosamine). When applied directly to a bleeding source, the gel rapidly adheres to the wound, forms a mechanical barrier that stops the flow of blood, and allows the body to create a natural clot.
How It Performs
- Controls severe bleeding fully within three minutes or less, depending on the treatment scenario and technique.
- Does not require wound packing — expelled directly into the wound.
- Conforms to irregular wound geometries and adheres across a variety of tissue types.
- Removed within 24 hours using saline lavage and gauze, prior to definitive wound repair.
- Can be used in conjunction with a tourniquet, so long as neither device interferes with deployment of the other.
Safety by Design
- All components are non-animal derived — sourced from algae and mushroom origin, with no shellfish-derived materials and no shellfish allergic-reaction risk.
- Terminally sterilized with gamma irradiation; the syringe and pouch interior are also gamma irradiated.
- Evaluated per ISO 10993 biocompatibility testing under FDA guidance; each lot meets pyrogenicity requirements per ISO 10993-11:2017 and USP <151>.
- Mechanism of action is primarily mechanical — may still be used in patients with known or treatment-induced coagulopathy and on anticoagulants such as Coumadin or Heparin.
- Does not cause an exothermic reaction and has no known or expected drug interactions.
Where It Can Be Used
- Scalp lacerations, road rash, and large tears.
- In certain instances — gunshot wounds, stabbings, lacerations, and amputations — so long as wounds are external, easily visible, amenable to pressure, and do not penetrate the abdominal or thoracic cavities.
- Across a variety of wound shapes and types, conforming to irregular geometries.
Relevance for First Responders
For first responders operating in the critical minutes before advanced care, rapid hemorrhage control saves lives — Seconds Matter™. TRAUMAGEL® requires no preparation, no wound packing, and no complex technique, allowing responders to control moderate-to-severe external bleeding quickly under field conditions. A supporting clinical evidence base spans peer-reviewed studies including JSOM, a JAVMA randomized control trial, OAEM (2025), and preclinical swine gunshot-wound research.
Continue the Conversation
Walker & Meier Consulting can walk your command staff and wellness officers through implementation, relevance, and agency impact.