Page 37 - Journal of Special Operations Medicine - Spring 2016

and may include an applicator to facilitate deliv- Figure 1 Photograph of one device, which consists of
ery into a wound.” 6 compressed sponges housed in a syringe-style applicator.
One device consists of three applicators.
Another important potential use of XStat is facilitat-
ing the conversion of extremity tourniquets to another
method of bleeding control. The TCCC Guidelines rec-
ommend that limb tourniquets be converted to other
methods of hemorrhage control, when feasible, if the
tourniquet is still in place 2 hours after application.
21
This is not an FDA-approved indication for this product
and there are currently no laboratory studies or clini-
cal reports that document efficacy for this use of XStat,
but this is an area that merits further consideration and
research.

XStat Descriptive Information (Photo courtesy of RevMedX)
XStat specifics include:

• The XStat system consists of approximately 92 flat, Figure 2 Photograph depicting side views of compressed and
circular, compressed minisponges that are coated with fully-expanded sponges. Radiopaque filaments are attached
chitosan and packaged in a 60mL syringe applicator to one end of each sponge in an “x” pattern.
(Figure 1). The unexpanded minisponges are 9 mm in
diameter and 4.5 mm in height (Figure 2). 14
• Each XStat minisponge has a radiopaque marker so
the sponges can be located with radiography at the
time of surgery. 22
• The applicator has a small-diameter insertion device
available for use in narrow wound tracts. 22
• Approved XStat indications are as follows: “XStat is
™
a hemostatic device for the control of bleeding from
junctional wounds in the groin or axilla not amenable
to tourniquet application in adults and adolescents.
XStat is a temporary device for use up to four (4)
™
hours until surgical care is acquired.” Although (Photo courtesy of RevMedX)
6
XStat was initially intended for use on the battlefield,
6
it has now been cleared for use in the civilian sector
as well. 23
• XStat is NOT approved for use in the thorax, the
pleural cavity, the mediastinum, the abdomen, the ret- XStat applicator is also now also commercially avail-
roperitoneal space, the sacral space above the ingui- able and carries NSN 6510-01-644-7335: APPLICA-
nal ligament, or tissues above the clavicle. Note that TOR, HEMOSTATIC SPONGES AND DISPENSER.
6
the latter restriction would preclude its use in maxil- • The present cost to the US Government for a single-
lofacial or neck wounds. pack XStat applicator is approximately $350; the cost
• The compact XStat syringe applicator includes a tele- for the three-pack of XStat applicators is currently
scoping handle and a sealed valve tip. The telescoping $1,050.
mechanism allows the handle to be stored in a short- • The shelf life for XStat recommended by the manufac-
ened state to maximize compactness. The applicator turer is presently 2 years. 24
tip is designed to prevent fluid ingress and to mini- • The size of a three-pack of XStat applicators is 6 × 10
mize the risk of premature sponge expansion. × 1.25 inches and the weight is 0.53 pounds. The size
• A National Stock Number (NSN) is necessary for an of a single-applicator pack of XStat is 2 × 10 × 1.5
item to be included in standardized Department of inches and the weight is 0.17 pounds.
Defense (DoD) equipment assemblages. The three-
pack of XStat applicators is commercially available Following FDA clearance in 2014, the manufacturer of
and NSN 6510-01-632-9440: APPLICATOR, HE- XStat, RevMedX, sent a shipment of XStat to Special
MOSTATIC in DoD logistics systems. The single-pack Forces units for its initial fielding. 25

TCCC Guidelines: XStat Sponge for External Hemorrhage 21