Management of Hemorrhage From Craniomaxillofacial Injuries and Penetrating Neck Injury in Tactical Combat Casualty Care: iTClamp Mechanical Wound Closure Device TCCC Guidelines Proposed Change 19-04 06 June 2019.

The 2012 study Death on the battlefield (2001-2011) by Eastridge et al.1 demonstrated that 7.5% of the prehospital deaths caused by potentially survivable injuries were due to external hemorrhage from the cervical region. The increasing use of Tactical Combat-Casualty Care (TCCC) and other medical interventions have dramatically reduced the overall rate of combat-related mortality in US forces; however, uncontrolled hemorrhage remains the number one cause of potentially survivable combat trauma. Additionally, the use of personal protective equipment and adaptations in the weapons used against US forces has caused changes in the wound distribution patterns seen in combat trauma. There has been a significant proportional increase in head and neck wounds, which may result in difficult to control hemorrhage. More than 50% of combat wounded personnel will receive a head or neck wound. The iTClamp (Innovative Trauma Care Inc., Edmonton, Alberta, Canada) is the first and only hemorrhage control device that uses the hydrostatic pressure of a hematoma to tamponade bleeding from an injured vessel within a wound. The iTClamp is US Food and Drug Administration (FDA) approved for use on multiple sites and works in all compressible areas, including on large and irregular lacerations. The iTClamp's unique design makes it ideal for controlling external hemorrhage in the head and neck region. The iTClamp has been demonstrated effective in over 245 field applications. The device is small and lightweight, easy to apply, can be used by any level of first responder with minimal training, and facilitates excellent skills retention. The iTClamp reapproximates wound edges with four pairs of opposing needles. This mechanism of action has demonstrated safe application for both the patient and the provider, causes minimal pain, and does not result in tissue necrosis, even if the device is left in place for extended periods. The Committee on TCCC recommends the use of the iTClamp as a primary treatment modality, along with a CoTCCC-recommended hemostatic dressing and direct manual pressure (DMP), for hemorrhage control in craniomaxillofacial injuries and penetrating neck injuries with external hemorrhage.

Worldwide Case Reports Using the iTClamp for External Hemorrhage Control.

BACKGROUND: Historically, hemorrhage control strategies consisted of manual pressure, pressure dressings, gauze with or without hemostatic ingredients for wound packing, or the use of tourniquets. The iTClamp is a relatively new alternative to stop external bleeding. METHODS: An anonymous survey was used to evaluate the outcomes of the iTClamp in worldwide cases of external bleeding. RESULTS: A total of 245 evaluable applications were reported. The iTClamp stopped the bleeding in 81% (n = 198) of the cases. Inadequate bleeding control was documented in 8% (n = 20) and in the remaining 11% (n = 27), bleeding control was not reported. The top three anatomic body regions for iTClamp application were the scalp, 37% (n = 91); arm, 20% (n = 49); and leg, 19% (n = 46). In 26% of the reported cases (direct pressure [23% (n = 63)] and tourniquets [3% (n = 8]), other techniques were abandoned in favor of the iTClamp. Conversely, the iTClamp was abandoned in favor of direct pressure 11 times (4.4%) and abandoned in favor of a tourniquet three times (1%). CONCLUSION: The iTClamp appears to be a fast and reliable device to stop external bleeding. Because of its function and possible applications, it has potential to lessen the gap between and add to the present selection of devices for treatment of external bleeding.

Abbreviated closure for remote damage control laparotomy in extreme environments: A randomized trial of sutures versus wound clamps comparing terrestrial and weightless conditions.

INTRODUCTION: Far-Forward Damage Control Laparotomies (DCLs) might provide direct-compression of visceral hemorrhage, however, suturing is a limiting factor, especially for non-physicians. We thus compared abbreviated skin closures comparing skin-suture (SS) versus wound-clamp (WC), on-board a research aircraft in weightlessness (0g) and normal gravity (1g). METHODS: Surgeons conducted DCLs on a surgical-simulator; onboard the hangered-aircraft (1g), or during parabolic flight (0g), randomized to either WC or SS. RESULTS: Ten surgeons participated. Two (40%) surgeons randomized to suture in 0g were incapacitated with motion-sickness, and none were able to close in either 1 or 0g. With WC, two completely closed in 1g as did three in 0g, despite having longer incisions (p = 0.016). Overall skin-closure with WC was significantly greater in both 1g (p = 0.016) and 0g (p = 0.008). CONCLUSIONS: WC was more effective in 1g and particularly 0g. Future studies should address the utility of abbreviated WC abdominal closure to facilitate potential Far-Forward DCL. TRIAL REGISTRATION: ID ISRCTN/77929274.

Damage control surgery in weightlessness: A comparative study of simulated torso hemorrhage control comparing terrestrial and weightless conditions.

BACKGROUND: Torso bleeding remains the most preventable cause of post-traumatic death worldwide. Remote damage control resuscitation (RDCR) endeavours to rescue the most catastrophically injured, but has not focused on prehospital surgical torso hemorrhage control (HC). We examined the logistics and metrics of intraperitoneal packing in weightlessness in Parabolic flight (0g) compared to terrestrial gravity (1g) as an extreme example of surgical RDCR. METHODS: A surgical simulator was customized with high-fidelity intraperitoneal anatomy, a "blood" pump and flowmeter. A standardized HC task was to explore the simulator, identify "bleeding" from a previously unknown liver injury perfused at 80 mm Hg, and pack to gain hemostasis. Ten surgeons performed RDCR laparotomies onboard a research aircraft, first in 1g followed by 0g. The standardized laparotomy was sectioned into 20-second segments to conduct and facilitate parabolic flight comparisons, with "blood" pumped only during these time segments. A maximum of 12 segments permitted for each laparotomy. RESULTS: All 10 surgeons successfully performed HC in both 1g and 0g. There was no difference in blood loss between 1g and 0g (p = 0.161) or during observation following HC (p = 0.944). Compared to 1g, identification of bleeding in 0g incurred less "blood" loss (p = 0.032). Overall surgeons rated their personal performance and relative difficulty of surgery in 0g as "harder" (median Likert, 2/5). However, conducting all phases of HC were rated equivalent between 1g and 0g (median Likert, 3/5), except for instrument control (rated slightly harder, 2.75/5). CONCLUSION: Performing laparotomies with packing of a simulated torso hemorrhage in a high-fidelity surgical simulator was feasible onboard a research aircraft in both normal and weightless conditions. Despite being subjectively "harder," most phases of operative intervention were rated equivalently, with no statistical difference in "blood" loss in weightlessness. Direct operative control of torso hemorrhage is theoretically possible in extreme environments if logistics are provided.

Remote Telementored Ultrasound-Directed Compression to Potentially Accelerate Hemostasis in Exsanguinating Junctional Vascular Injuries.

Bleeding to death has been identified as the leading cause of potentially preventable injury-related death worldwide. Temporary hemorrhage control could allow the patient to be transported to a site capable of damage- control surgery. A novel device that may offer a fast and effective means of controlling nontruncal bleeding (junctional and extremity) is the iTClamp (Innovative Trauma Care; http://innovativetraumacare.com). This case study demonstrated that a motivated and intelligent, but untrained, first responder could successfully localize the actual anatomic site of an exsanguinating bleed and then could relatively easily compress this site to control the bleeding site by using ultrasound-guided manual-compression techniques.

The marriage of surgical simulation and telementoring for damage-control surgical training of operational first responders: A pilot study.

BACKGROUND: Hemorrhage is the leading cause of preventable posttraumatic death. Many such deaths may be potentially salvageable with remote damage-control surgical interventions. As recent innovations in information technology enable remote specialist support to point-of-care providers, advanced interventions, such as remote damage-control surgery, may be possible in remote settings. METHODS: An anatomically realistic perfused surgical training mannequin with intrinsic fluid loss measurements (the "Cut Suit") was used to study perihepatic packing with massive liver hemorrhage. The primary outcome was loss of simulated blood (water) during six stages, namely, incision, retraction, direction, identification, packing, and postpacking. Six fully credentialed surgeons performed the same task as 12 military medical technicians who were randomized to remotely telementored (RTM) (n = 7) or unmentored (UTM) (n=5) real-time guidance by a trauma surgeon. RESULTS: There were no significant differences in fluid loss between the surgeons and the UTM group or between the UTM and RTM groups. However, when comparing the RTM group with the surgeons, there was significantly more total fluid loss (p = 0.001) and greater loss during the identification (p = 0.002), retraction (p = 0.035), direction (p = 0.014), and packing(p = 0.022) stages. There were no significant differences in fluid loss after packing between the groups despite differences in the number of sponges used; RTM group used more sponges than the surgeons and significantly more than the UTM group (p = 0.048). However, mentoring significantly increased self-assessed nonsurgeon procedural confidence (p = 0.004). CONCLUSION: Perihepatic packing of an exsanguinating liver hemorrhage model was readily performed by military medical technicians after a focused briefing. While real-time telementoring did not improve fluid loss, it significantly increased nonsurgeon procedural confidence, which may augment the feasibility of the concept by allowing them to undertake psychologically daunting procedures.

Tactical Hemorrhage Control Case Studies Using a Point-of-Care Mechanical Direct Pressure Device.

In 2012, a new hemorrhage control device entered the market, and by May 2013, the iTClamp 50 had acquired US Food and Drug Administration approval. The authors describe the use of the iTClamp 50 and present two case studies in which the iTClamp 50 was successfully used in the military environment to control potentially fatal hemorrhage.