Another adjunct highlighted in the TCCC Guideline section on massive hemorrhage control is the use of a wound closure device, either alone or in conjunction with a hemostatic dressing or XStat. The Guidelines then go on to state that for head and neck wounds where the edges can be approximated, a wound closure device can be used as a primary option.
The incidence of craniomaxillofacial injuries (CMFI) and penetrating neck injuries increased from approximately 16% in Vietnam to 30.0% in the first 4 years of conflict in Afghanistan and Iraq, probably as a result of improved body armor protecting other common sites of injury (torso) and the increased use of improvised explosive devices. As previously discussed, the anatomic complexities of the head and neck make wounds in this region a challenge to treat, especially for the Role 1 provider, as they are not amenable to tourniquet use or circumferential pressure dressings. Also, the anatomy of the scalp makes compression challenging, and packing with hemostatic dressing is usually not possible. And CMFI and neck injuries are associated with a 10% to 50% mortality rate due to exsanguination. In response to this, in September 2018, the CoTCCC reviewed the literature on the clinical and experimental use of the iTClamp® as a wound closure device, resulting in its inclusion in the next set of TCCC Guidelines.
Several studies have demonstrated the effectiveness of the iTClamp, including a 2018 review that found 245 reported uses, of which 81% achieved adequate control of bleeding, 8% failed to control bleeding, and 11% did not mention bleeding control. This wound closure device uses the hydrostatic backpressure of a hematoma inside a wound cavity to generate pressure and produce a hemostatic effect on the injured vessel. The device establishes a fixed fluid-tight seal through wound edge approximation, and this seal creates a hematoma that tamponades injured vessels via hydrostatic pressure to replace direct pressure on the injured vessel. In an animal model comparison to standard therapy with hemostatic dressings and pressure bandages combining the iTClamp and wound packing demonstrated improved survival and considerably reduced treatment times. Wound closure devices can be used with or without wound packing and hemostatic dressing for temporary wound closure and bleeding control (applying with hemostatic dressings is an off-label use, as this was not included in the FDA approval process).
The device is best suited for wounds on the scalp, neck, or extremities but can also be used on some junctional wounds in the groin or axilla. It can be applied quickly and if needed, can be removed and reapplied easily in the prehospital environment. For larger wounds or wounds with a significant cavity, more than one closure device and/or wound packing with hemostatic dressing prior to closure may be needed to control bleeding.