Page 55 - Journal of Special Operations Medicine - Winter 2014

Figure 9 Baseline laboratory measures were taken to ensure Table 2 Primary End Points*
no subset of animals had a metabolic or clotting anomaly
that might bias the study. No statistical differences between NuStat, Combat Fisher
baseline values were found. n = 8 Gauze, n = 7 Exact Test
Primary Metrics (Y/N) (Y/N) p Value
Immediate 8/0 4/3 .0475**
hemostasis (T0)
Hemostasis at 8/0 6/1 .4667
T60
Rebleed during 1/7 3/4 .2821
study
Notes: N, no; T0, time = 0 minutes; T60, time = 60 minutes; Y, yes.
*The primary end points of this study were binary Yes or No criteria
at T0, T60, and rebleed during the 60-min observation window.
**Statistically significant.

Kheirabadi et al. at the Institute for Surgical Research
16
in San Antonio, Texas, originally developed the 6.0mm
femoral punch model. The investigators used a 5.5mm
Note: ALT, alanine aminotransferase; BUN, blood, urea, nitrogen; arteriotomy punch, which we do not believe compro-
GGT, γ-glutamyl transpeptidase; GLOB, globulin; HGB, hemoglo- mised the model, as all injuries across both groups were
bin; K, potassium; MCH, mean corpuscular hemoglobin; MPV, mean created equivalently, as demonstrated by comparative
platelet volume; TP, total platelets; WBC, white blood cell count.
baseline metrics. It is important to note that many dif-
ferent groups have tested dressings in a swine femoral
Discussion
punch model. All will attest to the importance of creat-
Uncontrolled hemorrhage remains one of the primary ing an injury in which the porcine tissue will not con-
causes of morbidity and mortality in civilian and com- tribute to the cessation of hemorrhage. For example, it is
bat trauma. Medical and emergency providers require necessary to make an injury in which the vessel will not
methods to safely, effectively, and expediently control retract, vasospasm, or tamponade by the surrounding
hemorrhage in the prehospital and battlefield setting. It muscle, or without a sufficient length of vessel expo-
is well researched and understood that minimizing blood sure. This model addresses those concerns. Although this
loss improves survival. There are many modalities of he- model is not representative of wounds one may see in the
mostatic agent on the market, but the investigators were field or in the emergency department, it is reproducible,
intrigued by the pliability, size, and packability of NS, validated, challenging, and broadly studied.
and its lack of embedded biologic agent. The investiga-
tors sought to perform a comparative study to evaluate This model allowed us to successfully demonstrate the
equivalence between NS and the currently recommended differences between commonly used hemostatic dress-
dressing, CG, for evaluation of a novel adjunct dressing. ings and NS. Although this study was intended to show

Table 1 Baseline Metrics*
NuStat (n = 8) Combat Gauze (n = 7)
Baseline Metrics Mean SD Median Mean SD Median
Weight, kg 39.3 2.6 40.7 43.5 1.7 43.5
Temperature, °C 99.4 1.5 99.3 99.2 2.1 99.9
O sat, % 92.6 5.1 94.0 95.1 1.8 95.5
2
HR, bpm 82.9 15.7 76.0 78.4 7.7 77.5
MAP, mmHg 84.6 14.2 83.0 88.8 12.5 85.5
Diameter pre-lidocaine, mm 3.7 1.1 3.0 3.8 1.0 3.5
Diameter post-lidocaine, mm 5.7 1.0 5.0 5.4 0.7 5.0
30-sec bleed volume, mL 325.1 188.1 320.4 362.3 155.7 438.6
Cavity volume, mL 43.7 15.4 50.0 40.8 17.4 38.5
Cavity depth, cm 3.3 0.8 3.0 3.0 0.4 2.9
Notes: HR, heart rate; MAP, mean arterial pressure; O sat, oxygen saturation; SD, standard deviation.
2
*Clinically relevant baseline metrics were recorded and analyzed. There were no statistical differences between groups for any baseline metric.

Evaluation of NuStat Compared With Combat Gauze in Porcine Model 45