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一种使用基于硅酮的聚合物通用战斗基质治疗非压迫性躯干出血的新方法。

A Novel Approach to Noncompressible Torso Hemorrhage Using a Silicone-Based Polymer Universal Combat Matrix.

机构信息

SiOxMed, LLC, Winston-Salem, NC 27157, USA.

Department of Emergency Medicine, Kings County Hospital HHC New York, State University of New York Downstate Health Sciences University, Brooklyn, NY 11203, USA.

出版信息

Mil Med. 2024 Aug 19;189(Suppl 3):247-253. doi: 10.1093/milmed/usae085.

Abstract

INTRODUCTION

Battlefield trauma necessitates prompt hemostatic intervention to mitigate fatalities resulting from critical blood loss. Insights from Operation Enduring Freedom and Operation Iraqi Freedom emphasize the limitations of conventional methods, such as tourniquets, especially in noncompressible torso hemorrhage. Despite advancements in hemostatic agents, the evolving dynamics of multidomain operations necessitate novel, lightweight strategies for hemorrhage control. This study investigates the Silicone-Based Polymer (SBP) Universal Combat Matrix (UCM) by SiOxMed, a multimodal matrix exhibiting efficacy in lethal hemorrhage models. The study evaluates UCM's multiday hemostatic capabilities in a noncompressible torso hemorrhage model, offering pivotal insights for potential deployment in battlefield trauma.

MATERIALS AND METHODS

This research was performed under Institutional Animal Care and Use Committee approval and was designed to replicate austere conditions in an off-site enclosed facility. Yorkshire Hampshire swine underwent baseline assessments and anesthesia induction (n = 3). A Grade IV liver injury was made by incising X-shaped lesions, each measuring 4 cm × 2.5 cm, into the diaphragmatic surface of the left and right middle lobes using a scalpel blade, resulting in a lesion region of approximately 3 cm × 6 cm × 3 cm, followed by 30 seconds of uncontrolled bleeding. The injuries were then treated with SBP. Intensive care unit monitoring for 1 hour ensured sustained hemostasis, followed by 48 hours of postanesthesia monitoring and then a return to the operating table to visualize sustained hemostasis. Posteuthanasia, liver tissue underwent histological assessments to evaluate the hemorrhagic interface and liver tissue reactivity.

RESULTS

The average time to hemostatic control was 247.3 ± 71.3 seconds. Stable heart rate (81.3 ± 10.0) and respiratory rate (31.7 ± 16.5) were maintained during intensive care unit monitoring. All swine survived the 1-hour anesthesia monitoring period and the subsequent 48-hour monitoring (average survival time, 48.0 hours ± 0.0, n = 3). Visualization of the abdominal cavity at 48 hours revealed no hemorrhage. Histological assessment demonstrated aligned red blood cells and stratified layers of fibrin at the hemorrhagic interface. Masson's Trichrome analysis demonstrated a reactive and regenerative scenario 48 hours postinjury, with a collagen membrane demarcating uninjured and exposed liver regions, along with a comprehensive stromal response.

CONCLUSIONS

In conclusion, our investigation into the SBP UCM hemostatic efficacy in a grade IV liver laceration model demonstrates its rapid and reliable action in controlling bleeding, showcasing practicality with an average mass of 4.0 ± 1.0 g. Silicone-Based Polymer sustained hemostasis without adverse physiological effects, as evidenced by stable parameters and the survival of all swine during and after anesthesia. Macroscopic examination at 48 hours revealed durable adherence with no indications of hemorrhage. Histological evaluations highlighted SBP's role in stable clot formation, fibrinogenesis, and tissue regeneration, indicating its potential as a multimodal wound dressing. Although promising, the study has limitations, emphasizing the need for future research with larger samples and controls. This work sets the stage for exploring SBP's clinical implications, particularly in scenarios where lightweight, multimodal technologies are crucial for addressing traumatic injuries and enhancing military medical capabilities.

摘要

简介

战场创伤需要迅速止血干预,以减轻因大量失血导致的死亡。来自持久自由行动和伊拉克自由行动的经验表明,传统方法(如止血带)在非压迫性躯干出血时存在局限性。尽管止血剂有了进步,但多领域行动的不断发展需要新型、轻便的出血控制策略。本研究调查了 SiOxMed 的硅基聚合物(SBP)通用作战矩阵(UCM),这是一种在致命性出血模型中表现出疗效的多模式基质。该研究评估了 UCM 在非压迫性躯干出血模型中的多日止血能力,为其在战场创伤中的潜在部署提供了关键见解。

材料和方法

本研究得到机构动物护理和使用委员会的批准,并旨在在现场外封闭设施中模拟严峻条件。进行了基线评估和麻醉诱导(n=3)。使用手术刀在左、中肝叶的膈面切出 X 形损伤,每个损伤的长度为 4cm×2.5cm,形成 4cm×6cm×3cm 的损伤区域,然后让损伤处自由出血 30 秒,制造出四级肝损伤。然后用 SBP 处理伤口。在重症监护病房监测 1 小时以确保持续止血,然后进行 48 小时麻醉后监测,然后返回手术台观察持续止血。安乐死后,对肝组织进行组织学评估,以评估出血界面和肝组织反应。

结果

达到止血控制的平均时间为 247.3±71.3 秒。在重症监护病房监测期间,心率(81.3±10.0)和呼吸率(31.7±16.5)保持稳定。所有猪在 1 小时麻醉监测期和随后的 48 小时监测期(平均存活时间,48.0 小时±0.0,n=3)存活下来。在 48 小时时观察到腹腔无出血。组织学评估显示出血界面处的红细胞对齐和分层的纤维蛋白。Masson's Trichrome 分析显示,损伤后 48 小时出现反应性和再生性情况,胶原膜分隔未受伤和暴露的肝区,以及全面的基质反应。

结论

总之,我们在四级肝裂伤模型中对 SBP UCM 止血效果的研究表明,它在控制出血方面具有快速可靠的作用,平均重量为 4.0±1.0 克,具有实用性。硅基聚合物在没有不良生理影响的情况下维持止血,所有猪在麻醉期间和之后的存活情况证明了这一点。48 小时时的宏观检查显示持久的粘附,没有出血迹象。组织学评估强调了 SBP 在稳定凝块形成、纤维蛋白生成和组织再生中的作用,表明其作为一种多模式伤口敷料的潜力。尽管有希望,但该研究存在局限性,强调需要进行更多样本和对照的未来研究。这项工作为探索 SBP 的临床意义奠定了基础,特别是在需要轻便、多模式技术来解决创伤性损伤并增强军事医疗能力的情况下。

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