TRAUMAGEL for EMS: 30mL Syringe

Product Highlights:

• No preparation: unscrew the cap and apply; the gel is ready the moment the pouch is open³⁴
• Flowable gel reaches the bleeding source: the applicator tip goes deep into the wound track, so the gel fills irregular, junctional and hard-to-pack wounds³⁵
• Forms a mechanical barrier: the gel adheres to the wound and stops the flow of blood while the body forms its own clot; no thrombin or other biologics¹⁴
• Plant-based, non-animal derived: chitosan [poly(N-acetyl-D-glucosamine, D-glucosamine)] and sodium alginate in a viscous, opaque, tan gel¹³
• Easy removal at the hospital: the ED removes it within 24 hours with saline-soaked gauze and saline lavage³⁴
• Field evidence: hemostasis in 16 of 17 EMS patients in an initial case series, and tourniquet removal without rebleeding in published case reports⁶⁷
• FDA cleared under 510(k) K240713 (product code QSY), made by Cresilon in Brooklyn, New York¹⁸
• Shelf stable: store dry at 20 to 25 C (68 to 77 F); Cresilon lists a 2 year shelf life³⁹

Applications:

Clinical and Operational Use:

Hemorrhage is the leading cause of preventable trauma death, and about half of those deaths happen before the patient reaches definitive care.⁶ TRAUMAGEL adds a syringe-delivered gel to the EMS bleeding control toolkit of direct pressure, wound packing, hemostatic gauze and tourniquets.⁴⁸

How to apply TRAUMAGEL (summary of the Instructions for Use; it does not replace them):³¹⁰

1. Retrieve one syringe from the pouch. No preparation is needed.
2. Identify the bleeding source. Dry the wound with gauze or suction and clear as much blood as possible so the gel contacts the source.
3. Unscrew the applicator cap, insert the tip deep into the wound as close to the bleeding source as possible, firmly and quickly expel all contents, then withdraw.
4. Pack gauze into the wound opening on top of the gel. Hold moderate palm compression, hand over hand, for 3 minutes or until hemostasis. Do not eject the gel.
5. If misapplied, soak gauze with sterile saline, remove all the gel and repeat with a new syringe.
6. Do not remove correctly applied gel in the field. The emergency department removes it within 24 hours with saline-soaked gauze and saline lavage.

Contraindications and warnings: temporary external use only; not for surgical use; not a wound-closure device; do not use on wounds into the thoracic or abdominal cavity or on head wounds with a suspected underlying skull fracture. Single use only. Do not use with known sensitivity to sodium alginate or poly(N-acetyl-D-glucosamine, D-glucosamine). Do not inject intravascularly because of the risk of embolization.³ Follow your agency protocol, medical direction and the Instructions for Use.

Evidence. In a 17-patient EMS case series (April to August 2025) covering scalp, extremity, stab, gunshot and crush wounds, bleeding stopped within three minutes and stayed controlled through transport in 16 patients; the one failure was an application error.⁶ Case reports describe control of a scalp laceration in an 84-year-old on clopidogrel after pressure failed,¹¹ tourniquet removal without rebleeding in three extremity injuries,⁷ a partial hand amputation,¹² and a 15 x 7 x 10 cm junctional wound held for more than 2 hours with two syringes.⁵ In a US Army porcine femoral artery model, survival with TRAUMAGEL matched Combat Gauze (71.4% each), TRAUMAGEL was fastest to apply, and blood loss after treatment was higher than with an expanding sponge device.¹³ In a randomized trial in 18 calves, gel plus pressure stopped carotid bleeding in a median 170 seconds vs 1,134 seconds with pressure alone.¹⁴

Compatibility:

• Gauze on top of the gel. The IFU calls for gauze packed over the gel: Forward Cotton Gauze Slim Z-Fold, 6 ply, sterile or QuikClot EMS Rolled Gauze, 3 in x 4 yd.³
• Pressure dressing. Hold pressure with a Forward Trauma Compression Dressing, 4 inch after the 3 minute compression.¹⁰
• Tourniquets. Use with a Combat Application Tourniquet (C-A-T), Tactical Black or SAM XT Extremity Tourniquet, Hi-Viz Orange for extremity bleeding, and a SAM Junctional Tourniquet Deluxe for junctional wounds, per protocol.
• Hemostatic gauze. Many agencies carry gauze and gel together: QuikClot Combat Gauze LE, 3 in x 4 yd, QuikClot EMS 4x4 4-Ply Hemostatic Dressing and ChitoSAM 3 in x 4 ft Z-Fold Hemostatic Dressing.¹⁵
• Wound exposure. Cut clothing away with XShear 7.5 inch Titanium Coated Trauma Shears.
• Other formats. TRAUMAGEL 2.0 (K253609) and the compact Next Generation syringe use the same gel; the original 30 mL syringe stays available.¹⁶¹⁷ See the full hemostatic agents collection.

Specifications:

Related products:

• Forward Cotton Gauze Slim Z-Fold, 6 ply, sterile
• Forward Trauma Compression Dressing, 4 inch
• QuikClot Combat Gauze LE, 3 in x 4 yd
• QuikClot EMS 4x4 4-Ply Hemostatic Dressing
• ChitoSAM 3 in x 4 ft Z-Fold Hemostatic Dressing
• Combat Application Tourniquet (C-A-T), Tactical Black
• SAM XT Extremity Tourniquet, Hi-Viz Orange
• SAM Junctional Tourniquet Deluxe
• XShear 7.5 inch Titanium Coated Trauma Shears
• HALO Chest Seal Combo Pack

Frequently Asked Questions:

Specifications from Cresilon documentation and the TRAUMAGEL Instructions for Use. Pacific Biomedical is an Authorized Cresilon Distributor (USA). From Pacific Biomedical.