Exsanguinating hemorrhage is a primary cause of battlefield death. The iTClamp is a relatively new device (FDA approval in 2013) that takes a different approach to hemorrhage control by applying mechanism wound closure. However, no previous studies have explored the feasibility of utilizing the iTClamp in conjunction with hemostatic packing. To fill this important gap in the literature, a novel swine model was developed, and a total of 12 trials were performed using QuikClot Combat Gauze or XSTAT sponges in conjunction with the iTClamp to treat arterial injuries through 5 cm or 10 cm skin incisions in the groin, axilla, or neck. First-attempt application success rate, application time, and blood loss were recorded. Hemostasis was achieved on all wounds, though reapplication was required in one Combat Gauze and three XSTAT applications. Application averaged ~50% slower for Combat Gauze (M = 41 seconds, 95%CI: 22–32 seconds) than for XSTAT (M = 27 seconds, 95%CI: 35–47 seconds). XSTAT application was faster than Combat Gauze for each wound location and size. The 10 cm wounds took ~10 seconds (36%) longer to close (M = 27 seconds, 95%CI: 35–47 seconds) than the 5 cm wounds (M = 27 seconds, 95%CI: 35–47 seconds). Blood loss was similar for Combat Gauze (M = 51 mL, 95%CI: 25–76 mL) and XSTAT (M = 60 mL, 95%CI: 30–90 mL). Blood loss was roughly twice as great for 10 cm wounds (M = 73 mL, 95%CI: 47–100 mL) than for 5 cm wounds (M = 38 mL, 95%CI: 18–57 mL). This pilot study supports the feasibility of a novel model for testing the iTClamp in conjunction with hemostatic packing towards controlling junctional hemorrhage.
IntroductionThis study aimed to assess the qualitative and quantitative utility of MRI imaging to illustrate the magnitude and duration of the effect of a standard 100 µg dose of oxymetazoline in a commercially available formulation that also contains aromatic oils. MethodsThis was a randomized, open label, single dose, parallel group study in 21 adult male and female subjects who reported moderate to severe nasal congestion due to acute upper respiratory tract infection or hay fever. MRI scans were acquired using a 3T Philips Achieva scanner with a 16 channel head receive coil. High resolution MRI scans of the nasal turbinates were obtained immediately prior to dosing (baseline) and at approximately 1, 8, 10, 11, and 12 h after dosing. The efficacy variables of primary interest were inferior turbinate total volume at 8 and 12 h post-dosing. The secondary efficacy variables analysed were inferior turbinate total volume at 1, 10, and 11 h post-dosing, middle turbinate total volume at 1, 8, 10, 11, and 12 h post-dosing. ResultsChanges from baseline volumes measured for the inferior and middle turbinates of subjects receiving the oxymetazoline formulation showed significant (P < 0.05) decreases at all times up to and including 12 h postadministration. No significant decreases from baseline were detected in subjects receiving a sham 'spray' (untreated control -spray bottles with no spray solution). Statistical ANCOVA results of inferior and middle turbinate volume indicated significant differences (P < 0.05) at all measurement points up to and including 12 h post-administration between the oxymetazoline treatment group and the untreated control with the only exception the middle turbinate volume at 10 h (P = 0.0896). The significant changes were likely to be clinically relevant though this was not measured in the study. No AEs were reported during this study and no other safety evaluations were made. ConclusionsThis study showed that MRI assessment of nasal congestion in human volunteers is a robust, repeatable and viable measurement technique. The application of a 100 µg Vicks Sinex Micromist ® nasal decongestant (0.05% oxymetazoline solution) delivered a highly significant reduction in inferior and middle turbinate volumes compared with the application of a control, measurable by the MRI method up to and including a 12 h post-dose scan.
Introduction Prolonged field care for junctional wounds is challenging and involves limb movement to facilitate transport. No studies to date have explored the efficacy of gauze products to limit rebleeding in these scenarios. Materials and Methods We randomly assigned 48 swine to QuikClot Combat Gauze, ChitoGauze, NuStat Tactical, or Kerlix treatment groups (12 each) and then inflicted a severe groin injury by utilizing a modified Kheirabadi model of a 6-mm femoral artery punch followed by unrestricted bleeding for 60 seconds. We reassessed rebleed following limb movement at 30 minutes of stabilization and 4 hours after stabilization. Results Swine treated with Combat Gauze proved to have the lowest incidence of rebleeding, and conversely, NuStat Tactical had the highest incidence of rebleeding at wounds after limb movement. Importantly, rebleeds occurred at a rate of 25%-58% across all swine treatment groups at 30 minutes postinjury and 0%-42% at 270 minutes postinjury demonstrating that limb movements universally challenge hemostatic junctional wounds. Conclusions Our findings highlight the difficulty of controlling hemorrhage from junctional wounds with hemostatic gauze in the context of prolonged field care and casualty transport. Our research can guide selection of hemorrhage control gauze when patients have prolonged field extraction or difficult transport. Our data demonstrates the frequency of junctional wound rebleeding after movement and thus the importance of frequent patient reassessment.
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