Page 44 - JSOM Fall 2018

TABLE 3 iTClamp Application by Geographical Location

of the foot, which was a challenging area for application, and Discussion
in two of these five cases, the skin was too frail to support the
iTClamp; both of these cases were in elderly women. In 25% This retrospective observational study expands on the pre­
12
(n = 5), of the uncontrolled hemorrhage group, the wound vious smaller case series and allows for deeper probing of
required multiple devices to seal it, because the wound was the observations made therein. The results of the analysis of
longer than 5cm, but only one device was available. For an 245 cases confirm the findings of previous authors that the
13–24
additional 25% of cases (n = 5), the wound continued to bleed iTClamp was effective, with a demonstrated hemorrhage
externally despite iTClamp placement. In three cases (15%), it control rate of 81% (n = 198) and a reported failure rate of
was reported that the bleeding was controlled but not stopped. 8% (n = 20). This study further demonstrates that even with
There was one case of an expanding hematoma reported after a low failure rate of 8%, it is still important to have backup
a femoral artery injury, and for one case, the device was not tools and techniques to help deal with these hemorrhages. In
placed properly on the wound and since then the medic has 25% of cases (n = 63), direct pressure was abandoned in fa­
been retrained. In five of these 20 uncontrolled hemorrhage vor of an iTClamp, and in 3% (n = 8), tourniquet use was
cases, the iTClamp was reapplied; however, hemorrhage con­ abandoned in favor of an iTClamp. Tourniquets were used
trol was not achieved. In 50% (n = 10) of the uncontrolled to replace the iTClamp in 1% (n = 3) of cases. The number
hemorrhage cases, the device was not reapplied in an attempt of times when one control modality was not sufficient and
to gain hemorrhage control, and in the remaining 25% (n = 5) required a second modality illustrates the usefulness in having
of cases, it is unknown if the iTClamp was reapplied. an alternative modality available as backup when one or the
other is not successful in controlling hemorrhage.
In 26% of cases (n = 63), gauze and direct pressure was aban­ 18
doned in favor of the iTClamp and in 3% of cases (n = 8), a In the case series of Tan et al., 10 patients were treated by
tourniquet was abandoned, due to lack of bleeding control. In physicians in the prehospital setting and were selected from
25 cases (10%), the iTClamp was used initially without the at­ cases where the initial use of hemostatic agents did not work.
tempt of another hemorrhage control modality. In two of these One of these cases required a combination of a hemostatic
cases (1%), the iTClamp was combined with gauze right away, agent, iTClamp, and direct pressure to control a catastrophic
25
and in 59% of cases (n = 144), the use of other hemorrhage con­ neck hemorrhage. The article by Chovanes et al. highlights
trol modalities before iTClamp application was not reported. the failure of Combat Gauze (Z­Medica; www.z­medica.com/
healthcare) on its own to control a zone 1 neck injury in the
trauma room at Cooper Medical Center, but they succeeded in
When examining the use of other hemorrhage control modal­
ities after iTClamp application, in 11 cases (4.5%), gauze and controlling the hemorrhage and stabilizing the patient when
direct pressure were required; in three cases (1%), a tourni­ Combat Gauze was combined with the iTClamp. St. John et
23
quet was required. There were 12 cases (5%) in which the al. further confirmed the efficacy of dual­modality hemor­
iTClamp was combined with gauze after initial application to rhage control using a 100% lethal hemorrhage–control ani­
gain hemorrhage control. In two of the 12 cases (1%), the mal model (6mm femoral artery puncture). With this model,
iTClamp was combined with a tourniquet; in five cases (2%), St. John et al. demonstrated 100% survival with packing and
it was combined with direct pressure. In 86% of cases (n = iTClamp use. This was significantly better (p < .001) than
210), no other hemorrhage control modality was used or re­ packing alone, performed by an experienced packer, which
ported after iTClamp application. For three cases (1%), it had a survival rate of 12.5%.
was reported that staples were used, but it is not clear if the
staples were placed before or after the iTClamp placement. Use of the iTClamp has also evolved for treating external bleed­
Additional examination of the data revealed that three (1%) ing. As of this writing, a total of 19 peer­reviewed published ar­
needlestick injuries to the caregiver during iTClamp placement ticles have looked at the iTClamp as a hemorrhage control tool.
13–16,22,23,30,31
were reported; in two cases (1%), the iTClamp became dis­ Eight of these are preclinical studies , two are review
32,33
lodged after placement, and in one case (0.5%), the patient articles , and nine are reports from clinical case studies or
12,17–21,24,25,34
forcibly removed the device. case series that range from one to 24 patients (some

42 | JSOM Volume 18, Edition 3 / Fall 2018