The iTClamp® by Innovative Trauma Care is the only FDA-cleared hemorrhage control device that uses the hydrostatic pressure of a contained hematoma to tamponade bleeding from difficult, non-compressible wound locations. CoTCCC-recommended for craniomaxillofacial (CMF) injuries and penetrating neck wounds, the iTClamp controls severe bleeding in the scalp, neck, axilla, inguinal regions, and extremities in seconds — without wound packing, without manual pressure, and with minimal training.
Key Specifications
| Specification | Detail |
|---|---|
| Manufacturer | Innovative Trauma Care, Inc. |
| SKU | 631310 |
| Weight | 2.0 oz |
| FDA Clearance | 510(k) K123551 (extremities, axilla, inguinal), K132651 (scalp), K150813 (neck) |
| Regulatory Class | Class II — 21 CFR 870.4450 (Vascular Clamp) |
| CoTCCC Status | CoTCCC-recommended for CMF injuries and penetrating neck injuries with external hemorrhage |
| Mechanism | Self-locking clamp with 4 pairs of opposing suture needles; creates sealed hematoma tamponade |
| Application Sites | Extremities, axilla, inguinal areas, scalp, neck |
| Sterility | Sterile, single-use |
| Shelf Life | 5 years |
Product Overview
Hemorrhage in compressible zones — scalp, face, neck, axilla — represents a critical gap in conventional trauma care. Tourniquets cannot reach these sites. Wound packing requires manual pressure that ties up a provider's hands. Standard gauze dressings are often insufficient for highly vascular scalp or neck wounds that can bleed at rates of 500 mL/min or more. The iTClamp® was engineered specifically to fill this gap.
The iTClamp's mechanism of action is fundamentally different from all other hemorrhage control devices. Rather than applying external compressive force to the wound, the iTClamp® seals the skin edges closed using four pairs of opposing suture needles that penetrate and evert the skin margins. This creates a fluid-tight seal, causing blood to pool under pressure in the wound cavity as a contained hematoma. The hydrostatic pressure of this hematoma equalizes with the patient's arterial blood pressure — mechanically preventing further blood loss and allowing clot formation without ongoing manual pressure.
The clinical evidence base for the iTClamp is substantial. The Committee on TCCC (CoTCCC) reviewed evidence published in the Journal of Special Operations Medicine (JSOM) in 2019, including 245+ documented field applications and animal model data demonstrating statistically significant improvements in survival, survival time, and blood loss compared to packing alone or standard gauze. Based on this evidence, CoTCCC updated TCCC Guidelines to recommend the iTClamp as a primary treatment modality — alongside a CoTCCC-recommended hemostatic dressing and direct manual pressure — for hemorrhage control in craniomaxillofacial injuries and penetrating neck injuries with external hemorrhage.
Application Instructions
- Open the sterile package by flipping up one or both tabs on the top of the package
- Remove the device — grasp the top arms with one hand
- Position the needles approximately 1–2 cm (0.5–1 in.) from the wound edge on either side
- Align needle tips parallel to the wound edges
- Gently insert needles and close the device by squeezing the gripping bars together
- Ensure the wound is sealed, no gaps in skin, and no continued bleeding
- Device automatically locks in place — pressure bars create a fluid-tight seal
- Can be used with wound packing, hemostatic agents, or compression binding over the device
Wound Spectrum Coverage
The iTClamp fills a critical position in the hemorrhage control spectrum — between minor bleeding treated with topical dressings and tourniquet-accessible extremity amputations. Its primary value is in the 'difficult bleeding' category: highly vascular scalp lacerations, penetrating neck wounds with external hemorrhage, junctional groin or axillary wounds, and wounds where ongoing manual pressure is not feasible (single-provider scenarios, confined spaces, CASEVAC).
CoTCCC Recommendation (2019, TCCC Guidelines 19-04): The Committee on TCCC recommends the use of the iTClamp as a primary treatment modality, along with a CoTCCC-recommended hemostatic dressing and direct manual pressure (DMP), for hemorrhage control in craniomaxillofacial injuries and penetrating neck injuries with external hemorrhage.
See also: ITClamp Wound Pack Duo — Advanced Bundle
See also: Massive Hemorrhage Control Collection
See also: Hemostatic Agents
All products sourced from the actual brand manufacturer or authorized master distributors. CoTCCC recommendation status verified where applicable. Ships from MED-TAC International, Pembroke Pines, FL — clinician-founded, veteran-led, SDVOSB-certified.
