Page 42 - JSOM Fall 2018

the bars, which seal the skin over the wound. An adjustable
locking mechanism increases or decreases pressure across the
wound to achieve a fluid tight seal. This action stops the bleed­
ing, which may constitute definitive therapy or be temporizing FIGURE 5 Align the device parallel to the
until definitive surgical repair, depending on the wound. length of wound edge. Position the needles
about 1–2 cm (0.5–1 in.) from the wound
The iTClamp is a prescription­only disposable device indi­ edge on either side. Keep hands clear of the
cated for use for the temporary control of severe bleeding in wound area while applying the device.
the extremities, axilla, inguinal areas, scalp, and neck. The iT­
Clamp is contraindicated where skin approximation cannot
be obtained (e.g., large skin defects under high tension) and
will not control hemorrhage in noncompressible sites, such as
the abdominal and chest cavities. Figures 1–7 demonstrate iT­
Clamp application. Directions for use can be requested from
the iTraumaCare website (http://www.innovativetraumacare.
com/contact­us). FIGURE 6 Press the arms of device
together to close the device.

FIGURE 1 Open the package by
peeling off the package lid, using
the pull tab.

FIGURE 7 Ensure the entire wound is
sealed and bleeding stops.

FIGURE 2 Pull the device to For this study we examined the iTClamp cases that were re­
remove it from the package.
ported to Innovative Trauma Care via their spontaneous use
database. Cases can be reported to Innovative Trauma Care
in several ways. Practitioners can go online via the link in the
previous paragraph and report the case anonymously, they can
report the case directly to an Innovative Trauma Care staff
member, or, if they had serious concerns, they could report the
issue directly to the medical governing body appropriate for
their country (N.B., to date, iTraumaCare has not received any
reports this way).
FIGURE 3 Prepare the device
for use by pinching together the
device handles to open the device. Methods
NOTE: Ensure the device is fully
open before applying the device. Records of iTClamp use consistent with FDA­approved label­
ing were extracted from the postmarket surveillance database.
Data were reviewed and a descriptive analysis was applied.
Due to the nature of data collection, there was no way to val­
idate the data against an original source. However, the data
entry in the postmarket surveillance database was entered
by iTraumaCare’s clinical director and any cases with poten­
tial concerns were reviewed with the company’s regulatory
director.
FIGURE 4 Locate the wound edges.
During the descriptive analysis, we examined the number of
iTClamp cases reported, sex of the patients, version of the
iTClamp used, anatomic region of application, mechanism
of injury, time to apply the iTClamp, the country using the
iTClamp, adequate hemorrhage control proportion, reappli­
The iTClamp was released to the market in Canada in 2012 and cation requirements, and if other hemorrhage control devices
in 2013 in the United States and Europe. Since the iTClamp’s were required before and/or after iTClamp application. Cases
release, Innovative Trauma Care has maintained a spontaneous that were reported as inadequate hemorrhage control were ex­
reporting database for the iTClamp as part of a postmarket amined individually and any issues are reported. Data analy­
surveillance program. The online reporting survey for this da­ sis was completed using SPSS Statistics for Windows, version
tabase can be found at https://tinyurl.com/ITClamp1. 24.0 (IBM, www.ibm.com).

40 | JSOM Volume 18, Edition 3 / Fall 2018