A Randomized Controlled Trial using iTClamp, Direct Pressure, and Balloon Catheter Tamponade to Control Neck Hemorrhage in a Perfused Human Cadaver Model.

BACKGROUND: Penetrating neck wounds are common in the civilian and military realms. Whether high or low velocity, they carry a substantial morbidity and mortality rate. OBJECTIVES: We endeavored to ascertain whether the iTClamp is equivalent to direct manual pressure (DMP) and Foley catheter balloon tamponade (BCT). METHODS: Using a perfused cadaver, a 4.5-cm wound was made in Zone 2 of the neck with a 1-cm carotid arteriotomy. Each of the hemorrhage control modalities was randomized and then applied to the wound separately. Time to apply the device and fluid loss with and without neck motion was recorded. RESULTS: There was no significant difference between the fluid loss/no movement (p > 0.450) and fluid loss/movement (p > 0.215) between BCT and iTClamp. There was significantly more fluid lost with DMP than iTClamp with no movement (p > 0.000) and movement (p > 0.000). The iTClamp was also significantly faster to apply than the Foley (p > 0.000). CONCLUSIONS: The iTClamp and BCT were associated with significantly less fluid loss than DMP in a perfused cadaver model. The iTClamp required significantly less time to apply than the BCT. Both the iTClamp and the BCT were more effective than simple DMP. The iTClamp offers an additional option for managing hard-to-control bleeding in the neck.

The iTClamp controls junctional bleeding in a lethal swine exsanguination model.

OBJECTIVE: Severe hemorrhage is a leading cause of death and difficult to control even by trained medical personnel. Current interventions have significant limitations in the prehospital setting; therefore, a need exists for a new and effective treatment. iTraumaCare has designed a temporary wound closure device, the iTClamp, which controls external hemorrhage from open wounds within compressible zones. The device approximates the wound edges, sealing the skin within a pressure bar, enabling creation of a hematoma and subsequent clot formation. The objective of this study is to test the effectiveness of the iTClamp to control external bleeding due to a major vascular injury to the groin in an in vivo swine model. METHODS: Twenty Yorkshire-cross male swine were enrolled in this study. A complex groin injury was created by complete excision of the femoral artery and vein along with some surrounding muscle. The animals were divided into four treatment groups: control (no treatment), early iTClamp treatment, late iTClamp treatment, and standard gauze treatment. Survival rate, survival time, and blood loss were the primary endpoints. Physiologic parameters (heart rate, blood pressure, oxygen saturation) were monitored throughout the experiment and blood samples were collected to analyze partial thromboplastin time and fibrinogen. RESULTS: All (100%) of the animals treated with the iTClamp lived through the end of the experiment, compared to 60% in standard gauze treated and 0% of untreated control animals (early and late iTClamp vs. control and standard gauze, Fisher's exact, p = 0.003). Both the early iTClamp and late iTClamp treatment groups survived significantly longer than the untreated control pigs (Mann-Whitney U-test, p < 0.009). External blood loss was significantly lower in animals treated with the iTClamp (early) compared to no treatment (Mann-Whitney U-test, p < 0.008). There was no significant change in physiologic or hematologic parameters between treatment groups. CONCLUSIONS: The iTClamp showed statistically significant improvement in survival, survival time, and estimated blood loss when compared to no treatment. This proof-of-concept study demonstrates the potential of the iTClamp to control severe bleeding and prevent blood loss.

The iTClamp in the treatment of prehospital craniomaxillofacial injury: a case series study.

BACKGROUND: Craniomaxillofacial (CMF) injuries are very common in both civilian and military settings. Nearly half of all civilian trauma incidents include a scalp laceration and historical rates of CMF battle injuries increased from 16%-21% to 42.2%. The scalp is highly vascular tissue and uncontrolled bleeding can lead to hypotension, shock and death. Therefore, enabling on-scene providers, both military and civilian, to immediately manage scalp and face lacerations, in a manner that allows them to still function in a tactical way, offers operational advantages. This case series examines how effectively a wound-clamp (iTClamp) controlled bleeding from CMF injuries pre-hospital environment. METHODS: The use of the iTClamp for CMF (scalp and face laceration) was extracted from iTrauma Care's post market surveillance database. Data was reviewed and a descriptive analysis was applied. RESULTS: 216 civilian cases of iTClamp use were reported to iTrauma Care. Of the 216 cases, 37% (n=80) were for control of CMF hemorrhage (94% scalp and 6% face). Falls (n=24) and MVC (n=25) accounted for 61% of the mechanism of injury. Blunt accounted for 66% (n=53), penetrating 16% (n=13) and unknown 18% (n=14). Adequate hemorrhage control was reported in 87.5% (n=70) of cases, three respondents reported inadequate hemorrhage control and in seven cases hemorrhage control was not reported. Direct pressure and packing was abandoned in favor of the iTClamp in 27.5% (n=22) of cases. CONCLUSIONS: CMF injuries are common in both civilian and military settings. Current options like direct manual pressure (DMP) often do not work well, are formidable to maintain on long transports and Raney clips are a historical suggestion. The iTClamp offers a new option for control of external hemorrhage from open wounds within compressible zones.

Use of the iTClamp versus standard suturing techniques for securing chest tubes: A randomized controlled cadaver study.

OBJECTIVES: Tube thoracostomy (TT) is a common yet potentially life-saving trauma procedure. After successful placement however, securing a TT through suturing is a skillset that requires practice, risking that the TT may become dislodged during prehospital transport. The purpose of this study was to examine if the iTClamp was a simpler technique with equivalent effectiveness for securing TTs. MATERIALS AND METHODS: In a cadaver model, a 1.5 inch incision was utilized along the upper border of the rib below the 5th intercostal space at the anterior axillary line. TTs (sizes 28Fr, 32Fr, 36Fr and 40Fr) were inserted and secured with both suturing and iTClamp techniques according to the preset randomization. TT were then functionally tested for positive and negative pressure as well as the force required to remove the TT (pull test-up to 5 lbs). Time to secure the TT was also recorded. RESULTS: When sutured is placed by a trained surgeon, the sutures and iTClamp were functionally equivalent for holding a positive and negative pressure. Mean pull force for both sutures and iTClamp exceeded the 5 lb threshold; there was no significant difference between the groups. Securing the TT with the iTClamp was significantly faster (p < 0.0001) with the iTClamp having a mean application time of 37.0 ±â€¯22.8 s and using a suture had a man application time of 96.3 ±â€¯29.0 s. CONCLUSION: The iTClamp was effective in securing TTs. The main benefit to the iTClamp is that minimal skill is required to adequately secure a TT to ensure that it does not become dislodged during transport to a trauma center.

Evaluation of the iTClamp 50 in a human cadaver model of severe compressible bleeding.

BACKGROUND: Uncontrolled hemorrhage is a significant cause of preventable death. The iTClamp 50 is a temporary wound closure device designed to control bleeding within seconds of an injury. This study evaluates the ability of the iTClamp to control compressible bleeding in a human cadaver model. METHODS: Sterile water was pumped through the major arteries to mimic blood flow. Full-thickness, elliptical segments of skin were excised; arteriotomies or complete transections were performed on the major arteries in the thigh (distal femoral), groin (common femoral), neck (carotid), and arm (brachial). Scalp wounds were created by making a 4.4-cm linear incision to the level of the bone. Fluid losses from the wounds were compared with and without the iTClamp applied and with and without movement of the cadaver. Angiographic images of pressure-injected contrast were obtained of the neck and groin wounds. Hematoma volumes and needle penetration depth into the skin were measured. RESULTS: In all wounds tested, application of the iTClamp significantly reduced fluid loss in all wounds studied (p < 0.05), and movement of the cadaver did not affect the function of the iTClamp. For example, in one groin wound, the average fluid loss during 1 minute was reduced from 728.4 ± 79.3 mL to 5.6 ± 3.4 mL. Distal flow was maintained during application of the iTClamp, as illustrated in angiographic images obtained of the iTClamp applied to the neck and groin wounds. The average needle penetration depth into the skin was 4.21 ± 0.02 mm; furthermore, the iTClamp did not cause any visible skin damage or skin tearing. CONCLUSION: The iTClamp is effective at controlling fluid loss from open wounds within multiple compressible areas. The iTClamp does not occlude distal flow, and aside from small needle punctures, there was no other visible skin damage or skin tearing.

Evaluation of possible tourniquet systems for use in the Canadian Forces.

OBJECTIVE: Hemorrhage from extremity wounds is the leading cause of preventable death on the battlefield. Tourniquets have been identified as the most reasonable option for controlling life threatening extremity hemorrhage in the tactical phase of an operation. The purpose of this trial was to determine which tourniquet systems are effective under simulated combat conditions and make recommendations to the Canadian Forces (CF) on an approach to tourniquet use. METHODS: 5 tourniquet systems were tested: Self Applied Tourniquet System (SATS); One-Handed Tourniquet (OHT); tie & cravat Improvised Tourniquet (IT); pneumatic Emergency Medical Tourniquet (EMT); and latex surgical tubing (ST). On June 25, 2004, ten junior medics from 1 Field Ambulance volunteered for the study. They were divided into five groups of two and rotated through all tourniquets. Each group was timed on the speed of application, and effectiveness of the tourniquets on the lower limbs was determined by a Doppler probe and loss of palpable pulses. Subjective analysis by questionnaire was used to determine ease of use, durability, portability, patient comfort, and preference. RESULTS: Occlusion of the posterior tibial pulse, as measured by Doppler flow, occurred 0-10% of the time with the OHT, 40-50% with the SATS and IT, 70-80% with the EMT, and 90% with the ST. The presence of winter clothing did not change the effectiveness of the tourniquets. The OHT, SATS, IT, and EMT took an average of 30-40 seconds to apply while the ST took only 24 seconds. From most painful to least were: the IT (severe pain-could not tolerate); ST and SATS (moderate-severe pain); OHT (minor-moderate pain); and EMT (no pain-minor discomfort). CONCLUSIONS: The most effective tourniquets were the EMT and ST. The ST is also the lightest, fastest, easiest to learn, and the cheapest but it causes a lot of pain and presumably, local tissue damage. ST can be issued to every soldier with a minimum of training and used effectively in the "Care Under Fire" phase. The EMT, which causes the least pain and is equally effective, can be applied during the "Tactical Field Care" phase by the medic to replace the surgical tubing. Fine adjustments can be made to the EMT, which allows the medic to safely deflate the device, assess the wound, determine if a tourniquet is required, and re-inflate quickly if necessary.

The immunomodulatory effects of hypertonic saline resuscitation in patients sustaining traumatic hemorrhagic shock: a randomized, controlled, double-blinded trial.

OBJECTIVE: To investigate the potential immunologic and anti-inflammatory effects of hypertonic saline plus dextran (HSD) in hemorrhagic trauma patients. BACKGROUND: Unbalanced inflammation triggered by shock has been linked to multiorgan dysfunction (MOD) and death. In animal and cellular models, HSD alters the inflammatory response to shock, attenuating MOD and improving outcome. It remains untested whether HSD has similar effects in humans. METHODS: A single 250-mL dose of either HSD (7.5% NaCl, 6% dextran-70) or placebo (0.9% NaCl) was administered to adult blunt trauma patients in hemorrhagic shock. The primary outcome was to measure changes in immune/inflammatory markers, including neutrophil activation, monocyte subset redistribution, cytokine production, and neuroendocrine changes. Patient demographics, fluid requirements, organ dysfunction, infection, and death were recorded. RESULTS: A total of 27 patients were enrolled (13 HSD) with no significant differences in clinical measurements. Hyperosmolarity was modest and transient, whereas the immunologic/anti-inflammatory effects persisted for 24 hours. HSD blunted neutrophil activation by abolishing shock-induced CD11b up-regulation and causing CD62L shedding. HSD altered the shock-induced monocyte redistribution pattern by reducing the drop in "classic" CD14 and the expansion of the "pro-inflammatory" CD14CD16 subsets. In parallel, HSD significantly reduced pro-inflammatory tumor necrosis factor (TNF)-alpha production while increasing anti-inflammatory IL-1ra and IL-10. HSD prevented shock-induced norepinephrine surge with no effect on adrenal steroids. CONCLUSIONS: This first human trial evaluating the immunologic/anti-inflammatory effects of hypertonic resuscitation in trauma patients demonstrates that HSD promotes a more balanced inflammatory response to hemorrhagic shock, raising the possibility that similar to experimental models, HSD might also attenuate post-trauma MOD.