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Application of chain-based sponge dressing for gunshot wounds in the groin

  • Author Footnotes
    1 Weijin Yang and Junchuan Song are contributed equally to this work.
    Weijin Yang
    Footnotes
    1 Weijin Yang and Junchuan Song are contributed equally to this work.
    Affiliations
    Department of General Surgery, Dongfang Hospital, Xiamen University, China

    Department of General Surgery, The 900th Hospital of Joint Logistics Support Force, PLA, China
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  • Author Footnotes
    1 Weijin Yang and Junchuan Song are contributed equally to this work.
    Junchuan Song
    Footnotes
    1 Weijin Yang and Junchuan Song are contributed equally to this work.
    Affiliations
    Department of General Surgery, Dongfang Hospital, Xiamen University, China

    Department of General Surgery, The 900th Hospital of Joint Logistics Support Force, PLA, China
    Search for articles by this author
  • Yuewen Zhu
    Affiliations
    Department of General Surgery, Dongfang Hospital, Xiamen University, China

    Department of General Surgery, The 900th Hospital of Joint Logistics Support Force, PLA, China
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  • Zhi Ye
    Affiliations
    Department of General Surgery, Dongfang Hospital, Xiamen University, China

    Department of General Surgery, The 900th Hospital of Joint Logistics Support Force, PLA, China
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  • Mingwei Wang
    Affiliations
    Clinical Institute of Fuzhou General Hospital, Fujian Medical University, China
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  • Yongchao Fang
    Affiliations
    Department of General Surgery, The 900th Hospital of Joint Logistics Support Force, PLA, China
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  • Weihang Wu
    Affiliations
    Department of General Surgery, The 900th Hospital of Joint Logistics Support Force, PLA, China
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  • Dongsheng Chen
    Affiliations
    Department of Anaesthesiology and Perioperative Medicine, The 900th Hospital of Joint Logistics Support Force,PLA, China
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  • Yu Wang
    Correspondence
    Corresponding author at: Department Of General Surgery, Dongfang Hospital, Xiamen University, China.
    Affiliations
    Department of General Surgery, Dongfang Hospital, Xiamen University, China

    Department of General Surgery, The 900th Hospital of Joint Logistics Support Force, PLA, China
    Search for articles by this author
  • Author Footnotes
    1 Weijin Yang and Junchuan Song are contributed equally to this work.
Open AccessPublished:September 06, 2020DOI:https://doi.org/10.1016/j.ajem.2020.09.006

      Abstract

      Background

      With the application of limb tourniquet, junctional hemorrhage has outstripped extremity hemorrhage as the leading cause of death during recent conflicts in Afghanistan and Iraq. We used a gunshot wound femoral artery bleeding model to verify the effect of chain-based sponge dressing (CSD).

      Methods

      We used a rifle to shoot the femoral artery of female Bama miniature pigs to achieve a gunshot wound model. Pigs were immediately subjected to CSD (n = 4) or standard gauze (SG; n = 4) to achieve hemostasis. We compared outcomes between the CSD and SG groups.

      Results

      There was no significant difference in baseline data between the two groups. The average hemorrhage time was 38.75 ± 9.29 s after CSD and 630.75 ± 169.46 s after SG (p < 0.05). The success rate in the CSD group was 100% (4/4), while the success rate in the SG group was 25% (1/4). The survival time of the CSD group (120 min) was significantly longer compared with the SG group (62.25 min; p < 0.05). There was no statistically significant difference in the average time for removal of the hemostatic material between the two groups. One week after the experiment, animals had a normal diet and were walking. No secondary damage was caused by CSD.

      Conclusion

      We used a gun-shot wound model to verify the effectiveness of CSD in the groin area. CSD achieved hemostasis quickly in all animals, and mean arterial pressure remained at normal levels. These findings suggest that CSD may be appropriate for humans with junctional hemorrhage due to bullet wounds, although further research is needed.

      Keywords

      1. Introduction

      Uncontrolled hemorrhage is the leading cause of death during war, accounting for approximately 90.9% of survivable injuries. With the application of limb tourniquet, junctional hemorrhage has outstripped extremity hemorrhage as the leading cause of death [
      • Eastridge B.J.
      • Mabry R.L.
      • Seguin P.
      • et al.
      Death on the battlefield (2001−2011): implications for the future of combat casualty care.
      ]. Junctional hemorrhage refers to hemorrhage that occurs at the connection between the torso and the extremity, including the groin proximal to the inguinal ligament, the buttocks, the gluteal and pelvic areas, the perineum, the axilla, the shoulder girdle, and the base of the neck [
      • Mitchell T.A.
      • Wallum T.E.
      • White C.E.
      • et al.
      Evaluation of the effectiveness of the 2008 postsplenectomy vaccination joint theater trauma system clinical practice guideline.
      ]. These areas are prone to uncontrollable hemorrhage on the battlefield due to lack of protection from body armor and the distribution of major arteries with a rich blood circulation.
      Tactical Combat Casualty Care (TCCC) guidelines consider hemostasis as a top priority in first aid for the wounded. Hemostasis of junctional hemorrhage in the prehospital environment requires the assistance of trained professionals and first aid equipment [
      • Champion H.R.
      • Bellamy R.F.
      • Roberts C.P.
      • Leppaniemi A.
      A profile of combat injury.
      ]. There are three hemostatic devices currently recommended by TCCC guidelines for junctional hemorrhage: the Combat Ready Clamp (CRoC®), the Junctional Emergency Treatment Tool™ (JETT®), and the SAM® Junctional Tourniquet (SJT) [
      • Kotwal R.S.
      • Butler F.K.
      • Gross K.R.
      • et al.
      Management of junctional hemorrhage in tactical combat casualty care: TCCC guidelines?Proposed change 13-03.
      ]. The CRoC is effective, but feedback from military prehospital providers indicates that it is too bulky to perform on missions and is time-consuming to assemble [
      • Kotwal R.S.
      • Butler F.K.
      • Edgar E.P.
      • Shackelford S.A.
      • Bennett D.R.
      • Bailey J.A.
      Saving lives on the battlefield: a joint trauma system review of pre-hospital trauma care in combined joint operating area ? Afghanistan (CJOA-A) executive summary.
      ]. Unpublished data from a recent study indicated that the JETT has the potential to improve hemorrhage control in both junctional hemorrhage and pelvic fractures. The SJT is the only junctional tourniquet that is approved by the Food and Drug Administration for pelvic stabilization.
      New hemostatic devices, such as X-Stat® (RevMedx, Inc., Wilsonville, OR, USA). Each unit can quickly push 92 hemostatic sponges into the wound, which expands rapidly and fills deep, non-compressible wounds [
      • Sims K.
      • Montgomery H.R.
      • Dituro P.
      • Kheirabadi B.S.
      • Butler F.K.
      Management of external hemorrhage in tactical combat casualty care: the adjunctive use of XStatTM compressed hemostatic sponges: TCCC guidelines change 15-03.
      ]. However, it takes longer to remove each individual sponge compared with conventional gauze during deterministic surgery, which may cause patient discomfort. According to X-Stat instructions, sponges are deployed into the wound. If resistance is met, the applicator body should be retracted slightly to create additional packing space, and the handle should be depressed again. However, CSD simplifies the surgical procedure because it allows injection of hemostatic material into the gunshot wound while the injector is being withdrawn, so as to ensure enough space and reduce resistance for the material. The shell-based polysaccharide ingredient promotes clotting, which significantly increases the cost of the device [
      • Kragh Jr., J.F.
      • Aden J.K.
      • Steinbaugh J.
      • Bullard M.
      • Dubick M.A.
      Gauze vs XSTAT in wound packing for hemorrhage control.
      ]. We designed a CSD using a polyvinyl alcohol (PVA) expansion sponge. In earlier experiments, we demonstrated that this CSD can be successfully used for femoral hemorrhage [
      • Yang W.
      • Song J.
      • Zhou Y.
      • Wang Y.
      A novel chain-based sponge dressing for management of junctional hemorrhage.
      ]. In this study, we improved the device and used real-life gunshot wounds to verify its effectiveness.

      2. Materials and methods

      The CSD used in the present study is made of a PVA expansion sponge. Each miniature sponge is 1 × 1 × 0.45 cm and can expand 15 times in 20 s. Each unit contains 15 miniature sponges, which are connected by surgical suture (VICRYL, Johnson & Johnson) and packed into a 20-ml syringe.
      This study was approved by the Animal Care and Use Committee of 900 Hospital of the Joint Logistics Team, Fujian, China. All animals received care and were used in strict compliance with the Guide for the Care and Use of Laboratory Animals.

      2.1 In-vivo methods

      Eight female Bama miniature pigs aged two months and weighing 20–30 kg were purchased from Jiagan Biotechnology Co., Ltd., Shanghai, China. All animals were observed for seven days to ensure good health. The experimental group (n = 4) were subject to CSD and the control group (n = 4) were subject to standard gauze (SG).
      The day before the study, all animals were fasted for 12 h with ad-libitum access to water. On the day of the study, eight pigs were anesthetized with ketamine (0.3 ml/kg) and diazepam (0.1 ml/kg) intramuscularly. Anesthesia was maintained with pentobarbital (0.2 ml/kg) through the ear vein for fluid maintenance. A 6-F catheter was placed in the right carotid artery to monitor mean arterial pressure (MAP) and a 6-F catheter was placed in the right internal jugular vein for resuscitation.
      Animals were carried to the rifle range and fixed to a wooden frame. The projection position of the femoral body was marked using a red circular sheet of paper 30 m from the shooter. A QBZ-03 assault rifle (5.8 mm) was used to shoot the left groin area. After shots were fired, we observed whether artery damage had occurred in the groin area. If there was only intravenous bleeding without vascular damage, shots were fired again. Researchers setted off at a distance of 200 m and immediately treated the experimental animals. During this period, blood was collected using gauze and loaded into fresh bags for weighing (L1). The same amount of dry gauze was weighed (L2), and pretreatment blood loss was calculated by L1 − L2.

      2.2 Application of CSD

      We applied CSD to the wound and assessed blood loss after applying every device until the cavity was filled to the level of the skin incision. No external pressure was applied to the wound or dressing after the application of CSD. The duration of CSD was recorded as the application time. Animals were observed for 120 min to monitor bleeding. From the beginning of CSD, all blood was collected by gauze and was classified as posttreatment blood loss.

      2.3 Application of standard gauze

      Standard gauze was applied to the wound until the cavity was filled to the level of the skin incision. The wound was pressed manually for three minutes. Once hemostasis had occurred, compression was terminated. Otherwise, pressure was maintained for up to 12 min. From the beginning of SG application, blood was collected using gauze and was classified as posttreatment blood loss.

      2.4 Resuscitation

      MAP was measured by continuous arterial pressure monitoring using a carotid artery catheter. After injury, 500 ml of Hextend (6% hetastarch in balanced electrolyte solution + glucose) was infused via the catheter in the jugular vein at 33 ml/min to increase and maintain MAP between 60 mmHg and 65 mmHg. Fluid resuscitation with LR solution was continued at a rate of 10 ml/min as required to maintain MAP. A maximum volume of 1000ml of LR was infused.

      2.5 End points and statistical analysis

      The main measurements included pretreatment blood loss, posttreatment blood loss, MAP, volume of resuscitated fluid, and rate of survival. Animal survival was defined as a MAP of greater than 20 mmHg at the end of the experiment. At 120 min, the sponge and gauze were removed, the removal time was recorded, the presence or absence of hemorrhage was assessed, and the diameters of the entrance and exit wounds were measured. The wounds of surviving animals were stitched and observed for one week. Animals were then euthanized using pentobarbital.
      Data is expressed as mean ± standard deviation and the equality of between-group variances was tested using an F test. Statistical significance was attained with a 95% confidence level (P < 0.05). All analyses were performed using SPSS 23 statistical software.

      3. Results

      There was no significant difference in pretreatment animal weight, preinjury MAP, MAP after free bleeding, pretreatment blood loss, or removal time between the two groups. All wounds were penetrating. Table 1 shows the wound outcomes of the two groups.
      Table 1Outcomes of wounds
      OutcomeCSDSG
      Firing times1.75 ± 0.962 ± 0.82
      Entrance (mm)9.36 ± 2.1210.13 ± 1.36
      Exit (mm)29.5 ± 4.8128.38 ± 1.92
      Artery damage44
      Veins damage32
      Data are expressed as mean ± SD.
      Pretreatment blood loss between the two groups was not significantly different. Because of the small entrance and exit wound diameters (Table 1), gauze was difficult to put into the penetrating wound, so it could only be pressed on the wound surface for hemostasis and was useless for further hemostasis. In contrast, CSD plugged the wound easily, and hemostatic material was easily injected.
      The success rate in the CSD group was 100% (4/4), while the success rate in the SG group was 25% (1/4). As shown in Table 2, posttreatment blood loss in the CSD group was significantly lower compared with the SG group. The hemorrhage time in the CSD group was 38.75 ± 9.29 s and hemorrhage was stopped successfully. The hemorrhage time in the SG group was 630.75 ± 169.46 s (p < 0.05). The average time for removal of the hemostatic material was not significantly different between the two groups. The total resuscitation fluid volume in the CSD group was lower compared with the SG group.
      Table 2Outcomes of treating a groin arterial hemorrhage with CSD and SG
      OutcomeCSDSGp Value
      Stable hemostasis achieved4/41/4<0.001
      P < 0.05.
      Time of application (s)38.75 ± 9.29630.75 ± 169.460.006
      P < 0.05.
      Pretreatment blood loss (mL/kg)9.91 ± 0.2910.57 ± 2.220.561
      Posttreatment blood loss (mL/kg)4.42 ± 0.3743.75 ± 10.200.004
      P < 0.05.
      Total resuscitation fluid (mL/kg)14.33 ± 0.4654.32 ± 12.420.006
      P < 0.05.
      Survival rate (%)100%(4/4)25%(1/4)<0.001
      P < 0.05.
      Survival time (min)12062.5 ± 33.420.041
      P < 0.05.
      Time of remove(s)26.50 ± 2.2925.00 ± 2.940.245
      Data are expressed as mean ± SD.
      low asterisk P < 0.05.
      Fig. 1 demonstrates the trend in MAP for each group at specific points. In the CSD group, MAP immediately decreased to 53.5 ± 1.91 mmHg after shooting; after CSD was applied, MAP began to increase and reached 93.25 ± 6.29 mmHg at 120 min. In the SG group, MAP immediately decreased to 57.25 ± 1.5 mmHg after shooting; after SG was applied, MAP continued to decrease; the MAP of one pig began to increase at 60 min before finally reaching 68 mmHg, and that of the other three pigs dropped to 0 mmHg at 17, 63, and 72 min, respectively.
      Fig. 1
      Fig. 1MAP in the two groups treated with CSD and SG. After hemostatic treatment and fluid resuscitation, the MAP in the CSD group increased significantly and the MAP in the SG group decreased.
      The survival time in the CSD-treated group (120 min) was significantly longer compared with the SG-treated group (62.25 min) as shown in Fig. 2. Notably, one pig in the CSD group had a wound entrance diameter of 6 mm and an exit wound diameter of 430 × 350 mm with a tear wound. We used six tubes of CSD to successfully stop the bleeding, and the animal survived (Fig. 3). One week after the experiment, the surviving animals had a normal diet and were walking. There was no re-hemorrhage and no deaths occurred.
      Fig. 2
      Fig. 2A Kaplan–Meier analysis of survival time between the two groups. The CSD-treated animals lived significantly longer than SG-treated animals. *p < 0.05.
      Fig. 3
      Fig. 3CSD allowed injection of hemostatic material into the gunshot wound while the injector was being withdrawn. A huge tear wound on the back of the animal (a) underwent successful hemostasis (b).

      4. Discussion

      With advances in the design of body armor and helmets, the survival rate of soldiers in modern warfare has significantly improved. However, powerful improvised explosive devices have increased lower limb injuries near the groin area during wars in Iraq and Afghanistan [
      • Ficke J.R.
      • Eastridge B.J.
      • Butler F.K.
      • et al.
      Dismounted complex blast injury report of the army dismounted complex blast injury task force[J].
      ]. With the development of limb hemorrhage belts, the mortality rate from limb bleeding has gradually decreased, while the mortality rate from junctional hemorrhage has increased every year [
      • Kotwal R.S.
      • Butler F.K.
      • Gross K.R.
      • et al.
      Management of junctional hemorrhage in tactical combat casualty care: TCCC guidelines?Proposed change 13-03.
      ].
      Currently, the hemostatic materials recommended by the Committee on Tactical Combat Casualty Care include Combat Gauze®, Celox™ Gauze, and ChitoGauze®. These dressings are added to kaolin or chitosan, which achieve faster hemostatic onset and less total blood loss, have fewer requirements for fluid resuscitation, and enhance survival. These materials are commonly used for incompressible hemorrhage areas, such as the body surface. However, a penetrating wound may have a narrow entrance that is irregularly shaped with deep damage to vessels, muscles, and nerves. The common entrance of bullet wounds on the battlefield is narrow, and most wounds are penetrating; therefore, it is difficult to apply gauze to fill the wound completely and achieve hemostasis.
      There is no single animal model that can completely reproduce a real-life war injury situation. Achieving junctional hemorrhage and a variety of hemostatic dressing is a great challenge because of the deep vascular position and high blood volume. The femoral hemorrhage model is commonly used to verify the effectiveness of dressings. The model can reliably and stably cause femoral artery hemorrhage in the groin area, and can also be used for laboratory verification of hemostatic dressings [
      • Kheirabadi B.S.
      • Arnaud F.
      • McCarron R.
      • et al.
      Development of a standard swine hemorrhage model for efficacy assessment of topical hemostatic agents.
      ]. In earlier work, we used this model to verify the validity of CSD. The model usually requires a skin incision of approximately 6 cm and exposure of muscle and vessels to create a cavity ranging from 200 to 500 ml; however, the bullet wound diameter is relatively narrow depending on the size of the bullet. Therefore, we used a rifle to shoot the femoral artery to recreate a real gunshot wound using the femoral artery bleeding model.
      In this experiment, the wound entrance was relatively narrow, and traditional gauze was difficult to plug into the deep part of the wound to achieve hemostasis. On the other hand, CSD is easy to adapt to various types of gunshot wound. CSD can effectively prevent bleeding in the femoral artery.
      In terms of removal time, the CSD group and the SG group were no different. Meanwhile, CSD allowed sponges into the gunshot wound while the injector was being withdrawn synchronously, so that the sponges were injected smoothly into the wound to prevent sponges accumulation on the front of the device, which seemed to decrease the push resistance and operating duration. In the CSD group, there was no secondary damage or re-hemorrhage in the lower extremities one week after the experiment. All surviving animals walked normally after one week.

      4.1 Study limitations

      This study has limitation that should be highlighted. First, we used a gunshot wound model, which was at a distance of only 30 m from the animal. Second, not every shot can successfully hit the femoral artery to cause hemorrhage. Third, multiple shootings may cause bias.

      4.2 Conclusion

      In this experiment, we used a real gunshot wound model to verify the effectiveness of CSD in the groin area. CSD allows hemorrhage to be stopped quickly in all animals and maintenance of MAP at normal levels. These findings suggest that CSD may be appropriate to treat humans with junctional hemorrhage caused by bullet wounds, although further research is needed to clarify the findings presented in this study.

      Funding

      Financial support was provided by the Medical Science and Technology Major Projects of PLA ( CNJ15J004 ), the Fund project of the 900 Hospital of the Joint Logistics Team (NO. 2019Z07 ) and the Major national science and technology projects (NO. 2018ZX ).

      Declaration of Competing Interest

      The authors declare that they have no conflict of interest.

      Acknowledgments

      The authors would like to thank all participants who contributed to the study.

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