Page 42 - JSOM Fall 2019

changes in the epidermal or dermal layers surrounding the [95% CI 1.3 to 2.8], p = .001). This reduction in pain was
63
wounds that had an iTClamp applied. An additional study sustained throughout the study period.
was performed with an extended application time and similar
results. After 6 hours, the device was removed and skin prox- Conclusion
50
imal to the wound was excised. A control skin sample from
the same animal was excised for comparison. A veterinary The iTClamp is an effective mechanical hemorrhage con-
pathologist examined the samples, blinded to wound versus trol device for use in the head and neck to treat CMFI and
control samples. The histopathology demonstrated that the PNI with external hemorrhage. This device can be rap-
observed changes were consistent with an acute inflammatory idly applied, does not cause tissue damage even with ex-
process, such as would be expected following injury, but there tended use of up to 6 hours, and causes minimal pain. The
was no obvious necrosis or tissue destruction as a result of de- iTClamp can be used either alone or in combination with a
vice application. These findings indicate that tissue necrosis CoTCCC-recommended hemostatic dressing or XStat. Using
50
or injury does not occur even after extended use and that the the iTClamp eliminates the need for the 3 minutes of direct
device appears safe for application up to 6 hours. pressure that is required when using a hemostatic dressing.
Each iTClamp seals 5cm of wound opening and multiple de-
To assess what happens when an iTClamp is inadvertently dis- vices can be used in series to close longer wounds; however,
lodged from the skin during patient transport, a study was it may not be effective in wounds where skin edges cannot be
performed using both fresh thawed cadaver skin and abdom- easily approximated. Use of the iTClamp over delicate struc-
inal pig skin. The iTClamp was forcibly torn from the two tures such as the eye or within 10mm of the orbit is contrain-
51
types of skin at three different angles: horizontally along the dicated. Usability and safety studies demonstrate that medical
long axis of the device; horizontally along the short axis of the personnel of all experience levels can safely and effectively
device; and vertically upward from the wound. The force re- use the iTClamp with easy skill acquisition and knowledge
quired to remove the device was measured. In all 60 attempts retention. Its low cost, light weight, small profile, and durable
to remove the device, there was no tearing or additional dam- design are all highly desirable features for use in the combat
age seen on the skin aside from the presence of eight small environment.
holes (the equivalent of a 21-gauge needle) (Figure 14). An av-
erage of 10 pounds of force was required to remove the device,
and 7% of the devices remained in place after the maximum
pulling weight of 22 pounds was applied. This study helps to PROPOSED CHANGE
establish the iTClamp’s safety for use in the combat environ- TO THE TCCC GUIDELINES
ment where casualties often have to be moved and there is a
significant possibility of traumatic dislocation.
Current wording
The iTClamp has been shown to be well tolerated by patients, Tactical Field Care
especially compared with tourniquets. A study was performed
in 2015 using 13 trained police marksmen to determine 3. Massive Hemorrhage
whether the application of the iTClamp impairs marksman- a. Assess for unrecognized hemorrhage and control
ship. Pain was a secondary outcome measure. Application all sources of bleeding. If not already done, use a
63
of the iTClamp to healthy volunteers was compared to a simi- CoTCCC-recommended limb tourniquet to control
lar group on whom Combat Application Tourniquets (C-A-T) life-threatening external hemorrhage that is anatomi-
were applied. Marksmanship was tested at 5, 10, 15, 30, and cally amenable to tourniquet use or for any traumatic
60 minutes postapplication. Six subjects were randomized to amputation. Apply directly to the skin 2 to 3 inches
the C-A-T group and seven to the iTClamp group. Subject par- above the bleeding site. If bleeding is not controlled with
ticipation in the study ended if the range safety officer thought the first tourniquet, apply a second tourniquet side-by-
that the subject could no longer handle their weapon safely, if side with the first.
the subject reported a pain level ≥8 on a 0-to-10 Likert scale, or b. For compressible (external) hemorrhage not amenable
if the subject voluntarily withdrew. Of the six C-A-T subjects, to limb tourniquet use or as an adjunct to tourniquet
one subject was unable to complete the 5-minute shoot, five removal, use Combat Gauze as the CoTCCC hemostatic
subjects completed the 5-minute shoot but not the 10-minute dressing of choice.
shoot, and one subject completed the 10-minute shoot. None • Alternative hemostatic adjuncts:
of the C-A-T group completed the 15-minute shoot. Four of – Celox Gauze or
the C-A-T group were stopped for unsafe weapons handling – ChitoGauze or
or inability to fire their weapons and two withdrew due to – XStat (best for deep, narrow-tract junctional
pain. All seven subjects in the iTClamp group maintained pre- wounds)
cision to 60 minutes. • Hemostatic dressings should be applied with at least
3 minutes of direct pressure (optional for XStat).
Initial pain scores between the two groups were not signifi- Each dressing works differently, so if one fails to con-
cantly different (p = .09) but the 5- and 10-minute tourniquet trol bleeding, it may be removed and a fresh dressing
pain scores were significantly higher than the iTClamp pain of the same type or a different type applied. (Note:
scores (6.6 ± 1.5 versus 1.0 ± 0.58, −5.6 [95% CI −7.0 to XStat is not to be removed in the field, but additional
−4.3], p < .001, and 8.5 ± 0.6 versus 1.0 ± 0.6, −7.5 [95% CI XStat, other hemostatic adjuncts, or trauma dress-
−8.3 to −6.7], p < .001, respectively). The iTClamp subjects ings may be applied over it.)
63
experienced a decrease in pain between the initial application • If the bleeding site is amenable to use of a junc-
and the 5-minute pain scores (3.0 ± 1.0 versus 1.0 ± 0.6, –2.0 tional tourniquet, immediately apply a CoTCCC-

40 | JSOM Volume 19, Edition 3 / Fall 2019