Page 92 - JSOM Winter 2022

overall between treatment groups at each time point or within are challenging to manage due to their noncompressible nature
treatment groups compared to their respective baselines. and the limited and variable efficiencies of existing devices. 7,13
Controlling a junctional hemorrhage with direct pressure is
Respiration Rate an effective, and sometimes the only available, method. Here,
The average of the three, baseline RR measures was not sig- we show that in small, linear wounds pressure may also be
nificantly different between treatment groups (p = .53). Within provided by a mechanical wound closure device. The use of
CG-treated swine, RR was significantly lower compared to the iTClamp, both in isolation and in conjunction with he-
their own baseline (5 minutes to 15 minutes) following CG mostatic packing, resulted in faster application times without
application (p < .05) (Figure 4B). There were no other signifi- compromising hemostatic efficacy compared to manual pres-
cant differences in RR between treatment groups at each time sure with CG.
point or within treatment groups compared to their respective
baselines. TABLE 3 Outcome Measures
Outcome IT+XS IT+CG IT CG
FIGURE 4 Vital signs during experiment.
Initial 5/8 (63%) 6/8 (75%) 8/9 (88%) 7/7 (100%)
(A) hemostasis
Rebleed 2/8 (25%) 1/8 (13%) 1/9 (11%) 1/7 (14%)
Survival 7/8 (88%) 8/8 (100%) 9/9 (100%) 6/7 (86%)
Initial hemostasis, rebleed, and survival are tabulated as fraction of
total swine experiencing each outcome measure.
IT = iTClamp, CG = Combat Gauze, IT+XS = iTClamp with XSTAT,
IT+CG = iTClamp with Combat Gauze.
Our findings support prior studies demonstrating the ability
of the iTClamp to effectively stop hemorrhage. 6,9,14 Addition-
ally, we demonstrated that hemostatic agent packing can be
successfully combined with iTClamp treatment. A study by St.

John et al. previously noted that the use of the iTClamp in
conjunction with standard gauze resulted in less blood loss
and greater survival than packing with standard gauze alone.
However, these benefits appeared to be lost if pressure was
14
(B) held on the wound for 3 minutes after packing. This suggests
that the use of the iTClamp is functionally equivalent to 3
minutes of manual pressure, with our data showing similar
blood loss between treatment groups supports.
The iTClamp functions by direct wound closure. The wound
edges are everted, and the inguinal cavity is compressed to a
greater extent than in its preinjury state. Additionally, this ex-
erts a greater pressure on the bleeding site creating a tampon-
ade effect aiding in coagulation. Of course, as this mechanism
relies on creating a smaller compartment to control hemor-
rhage, complex wounds involving multiple anatomic compart-
ments may see reduced or limited efficiency. This was observed
during two of the IT treated swine in which a superficial he-
matoma formed and subsequently appeared to spontaneously
resorb. Evaluation of the wound at necropsy revealed that the
pressure of the hematoma had caused a separation of fascial
(A) Heart rate over time for iTClamp with XSTAT (IT+XS), iTClamp
with Combat Gauze (IT+CG), iTClamp alone (IT), and Combat planes and bleeding into adjacent compartments. While this
Gauze with pressure dressing (CG). (B) Respiration rate over time would lead to some increased blood loss verses intact facial
for iTClamp with XSTAT (IT+XS), iTClamp with Combat Gauze planes, the overall volumes would be comparatively small and
(IT+CG), iTClamp alone (IT), and Combat Gauze with pressure dress- total blood loss was not significantly greater across treatments.
ing (CG). Symbols represent the average; error bars represent standard
deviation.
Direct comparison of hemostasis between pressure dressing

Survival and iTClamptreatment groups was difficult to interpret due to
Overall, 94% (29 of 31) of swine survived during the obser- the differences in their mechanisms. As the iTClamp does not
vation period. One death occurred in each of the IT+XS and cover a wound but is intended to seal it, any bleeding from the
CG treatment groups. No statistically significant differences wound was considered a failure in initial hemostasis. On the
between groups in survival were revealed: χ (df = 3) = 2.30, other hand, the assessment of hemostasis failure was limited
2
p = .52 (Table 3). in the CG treatments. The CG covers the wound, and in addi-
tion to the packed combat gauze, the pressure dressing could
absorb a significant amount of blood before showing signs of
Discussion
blood loss. However, this limitation would only bias the results
Lethal hemorrhage is a time critical disease requiring rapid and against the effectiveness of the iTClamp, and yet the iTClamp
effective control to prevent mortality. Junctional hemorrhages was found to be similarly effective as CG alone.

90 | JSOM Volume 22, Edition 4 / Winter 2022