Bioadhesive/Mesh Constructs for Incisional Hernia Prevention

描述（由申请方提供）：用于预防切口疝的生物粘附/补片结构。尽管现在许多外科手术都使用腹腔镜技术进行，但大量腹部手术仍然需要剖腹手术。2%至23%的剖腹手术闭合导致腹部切口疝，在美国每年估计进行400，000例切口疝修补术。当考虑到初次疝修补术后的复发率通常在20%至25%之间时，这种医疗保健负担变得显著放大。切口疝修补术的平均住院费用估计在1万至1.5万美元之间，每年总计40 - 60亿美元。如果引入可靠的预防方法，即使切口疝的发病率降低20%，仅医院费用的节省估计将从8亿美元到12亿美元不等。切口疝的预防是一个重要的未满足的临床需求。尽管一直在努力降低疝的风险，但切口疝的发生率仍然相对稳定，并且对于降低这种风险的最佳方法没有达成共识。虽然没有单一的方法被证明是一种有效的疝预防策略，但大多数研究表明，通过更好的手术材料和技术可以降低风险。本I期提案的目标是通过在筋膜切口上方的浅筋膜上的贴敷位置放置粘合剂涂层补片来确定加强剖腹手术传统缝合闭合的可行性。粘合剂涂层补片将以剥离和粘贴方式应用于浅筋膜的连续缝合修复，从而加强这种闭合。这项新技术的灵感来自于海洋贻贝分泌的粘附蛋白。即使在潮湿、湍流和含盐的环境中，这些粘附蛋白也能迅速硬化，使海洋贻贝能够将自己锚在各种表面上。Nerites公司已经开发了一系列这些粘合蛋白的合成版本，这些粘合蛋白可以采取液体的形式，可以喷涂或涂在组织上，或者可以浇铸成干燥的薄膜或膜，可以单独使用或与合成或生物网片或支架结合使用。本I期项目将评价几种粘合剂/补片配方，并根据强度、吸收和生物相容性的性能指标对其进行表征。将在切口疝的啮齿动物模型中证明该方法的可行性。 公共卫生相关性：预防切口疝是一项重要的未满足的临床需求。除了对患者结局和生活质量的显著影响外，美国每年用于切口疝修补术的费用约为40 B美元。如果引入可靠的预防方法，即使将切口疝的发病率降低20%，仅医院费用的节省估计将从8亿美元到12亿美元不等，大约80，000名患者将受益。

DESCRIPTION (provided by applicant): Bioadhesive/Mesh Constructs for Incisional Hernia Prevention. Although many surgical procedures are now performed using laparoscopic techniques, a large number of abdominal surgeries still require a laparotomy. From 2% to 23% of laparotomy closures result in herniation of the abdominal incision, and an estimated 400,000 incisional hernia repairs are performed annually in the US. This healthcare burden becomes significantly amplified when considering that recurrence rates after initial hernia repair typically range from 20% to 25%. Mean hospital costs for incisional hernia repair are estimated to be between $10K and $15K, for a total of $4-6 Billion annually. If introduction of a reliable method for prophylaxis resulted in even a 20% reduction in the incidence of incisional hernias, the savings in hospital costs alone would range from an estimated $800 Million to $1.2 Billion. Prevention of incisional hernias represents a significant unmet clinical need. Despite ongoing efforts to reduce the risk of herniation, the incidence of incisional hernias has remained relatively steady, and there is no consensus as to the best way to reduce this risk. Although no single approach has proven itself to be an effective hernia prevention strategy, the majority of studies indicate that risk reduction is possible through better surgical materials and techniques. The goal of this Phase I proposal is to establish the feasibility of reinforcing the traditional suture closure of laparotomies by placement of an adhesive-coated mesh in an on-lay position on the superficial fascia over the fascial incision. The adhesive coated meshes will be applied in a peel-and-stick manner over the continuous suture repair of the superficial fascia, thereby reinforcing this closure. The inspiration for the novel technology comes from the adhesive proteins secreted by marine mussels. Even in a wet, turbulent and saline environment, these adhesive proteins harden rapidly and enable marine mussels to anchor themselves to various surfaces. Nerites Corporation has developed a series of synthetic versions of these adhesive proteins that can take the form of a liquid that can be sprayed or painted onto tissue, or that can be cast into dry thin films or membranes that can be used alone or in conjunction with synthetic or biologic meshes or scaffolds. This Phase I project will evaluate several adhesive/mesh formulations and characterize them based the performance metrics of strength, resorption, and biocompatibility. Feasibility of the approach will be demonstrated in a rodent model of incisional hernia. PUBLIC HEALTH RELEVANCE: Prevention of incisional hernias represents a significant unmet clinical need. Apart from the significant impact on patients' outcome and quality of life, around $4 B is spent annually in the US on incisional hernia repairs. If introduction of a reliable method for prophylaxis reduced the incidence of incisional hernias by even 20%, the savings in hospital costs alone would range from an estimated $800 million to $1.2 billion dollars and around 80,000 patients would benefit.