Page 36 - Journal of Special Operations Medicine - Spring 2016

“. . . as a hemostatic device for the control of Task Force on DCBI as “. . . hemorrhage that occurs at
bleeding from junctional wounds in the groin or the junction of an extremity with the torso of the body
axilla not amenable to tourniquet application in at an anatomic location that precludes the effective
adults and adolescents. XStat is a temporary use of an extremity tourniquet to control the bleeding.
™
device for use up to four (4) hours until surgical The definition also includes the base of the neck.” 5,19
care is acquired. XStat is intended for use in the Wounds from dismounted improvised explosive device
™
battlefield. XStat is not indicated for use in: the (dIEDs) became increasingly prevalent in Afghanistan
™
thorax; the pleural cavity; the mediastinum; the at the end of 2010 and often include high unilateral
abdomen; the retroperitoneal space; the sacral or bilateral lower-extremity amputations. The injury
19
space above the inguinal ligament; or tissues above pattern that results from pressure-plate activated dIEDs
the clavicle.” 6 often includes severe injuries to the urogenital, pelvic,
and abdominal areas, as well as lower-extremity ampu-
6. A study conducted at the Naval Medical Research tations. External hemorrhage from both the proximal
3
Unit-San Antonio comparing XStat to Combat Gauze in extremity amputations seen in DCBI and from other
a large-animal model of subclavian bleeding found that sites of external bleeding may be controllable with he-
XStat was applied in less time than Combat Gauze (31 mostatic dressings 4,20 or junctional tourniquets, but the
5
seconds versus 65 seconds) and resulted in less blood large variability of combat wound morphology requires
loss during the application time. 7 that combat medical providers have a variety of options
with which to address this prominent type of potentially
preventable death. XStat is another important tool for
Background the control of external hemorrhage that should be con-
sidered for addition to the Combat Medic aid bag.
Control of External Hemorrhage
The majority of combat fatalities result from severe in-
juries that are inevitably fatal; some fatalities, however, XStat
result from wounds that are potentially survivable. To address the challenge of controlling external hemor-
1,8
Eastridge et al. found that 87% of the combat fatalities rhage from sites where the bleeding vessel is deep in a
resulting from wounds sustained during the Iraq or Af- wound with a narrow entrance track, researchers from
ghanistan conflicts between 2001 and 2011 occurred in Oregon Biomedical Engineering Institute have devel-
the prehospital phase of care. Further, they found that oped a unique, new hemostatic product called XStat.
1
24.3% of these battlefield deaths resulted from wounds The XStat device consists of an applicator syringe filled
that were potentially survivable. Of those deaths that re- with compressed minisponges that are coated with the
sulted from potentially survivable wounds, 90.9% were hemostatic agent chitosan. XStat is injected into the
due to truncal, junctional, or extremity hemorrhage. wound cavity and the compressed hemostatic mini-
1
Despite the aversion to tourniquet use that prevailed in sponges expand on contact with blood. The expanded
US trauma care in the past, since 1996, the TCCC Guide- sponges, now 12–15 times their original volume, exert
lines have recommended the use of limb tourniquets as pressure on the walls of the wound cavity from within,
the initial intervention of choice for life-threatening ex- thereby eliminating the need for manual compression.
tremity hemorrhage on the battlefield. Although most
10
US Military units did not use limb tourniquets early in On 3 April 2014, the FDA granted de novo clearance
the conflicts in Afghanistan and Iraq, tourniquets began of the XStat dressing under regulation number 21 CFR
to be widely used in the military in the 2005–2006 time 878.4452, creating a new classification of medical de-
frame due to the combined efforts of the Committee vice designated generically as follows:
on TCCC (CoTCCC), the US Army Institute of Surgi-
cal Research, the US Special Operations Command, and “Non-absorbable, expandable, hemostatic sponge
the US Central Command. 11–16 This resulted in a large for temporary internal use: A non-absorbable,
reduction in preventable deaths from extremity hemor- expandable, hemostatic sponge for temporary
rhage and saved the lives of an estimated 1,000 to 2,000 internal use is a prescription device intended
US Military Servicemembers. 11,17,18 to be placed temporarily into junctional, non-
compressible wounds, which are not amenable to
With this remarkable reduction in mortality from ex- tourniquet use, to control bleeding until surgical
tremity wounds, junctional hemorrhage (which, by care is acquired. The sponges expand upon con-
definition, is not amenable to control with limb tourni- tact with blood to fill the wound cavity and pro-
quets) has become the leading cause of potentially pre- vide a physical barrier and pressure that facilitates
ventable death from external hemorrhage. Junctional formation of a clot. The device consists of sterile,
1
hemorrhage was defined by the Army Surgeon General’s non- absorbable, radiopaque, compressed sponges

20 Journal of Special Operations Medicine Volume 16, Edition 1/Spring 2016