SBIR Phase I: Development of a barrier film to prevent post-operative internal scarring

第一阶段的项目是提高对腹部手术引起的内部瘢痕患者的护理质量。严重瘢痕形成的患者通常需要后续的外科手术，称为粘连松解术。粘连松解术是为了切除连接不同器官或引起肠梗阻的内部疤痕。美国每年进行540，000例粘连松解术。这些二次外科手术也会导致额外的疤痕形成，从而导致重复手术的循环。虽然目前的屏障产品可以将内部疤痕的严重程度降低51%，但它们都会在几周后降解。此外，这些器械均未获批用于腹腔镜手术（粘连松解术的推荐技术）。传统上，用于减少疤痕的产品是由可降解的材料制成的。相比之下，拟议中的设备是由一种非降解材料制成的，在过去的40年里，这种材料一直安全地用于人体。这种更坚固的材料使腹腔镜使用成为可能，并确保内部器官的分离。因此，该设备在试点研究中显示出了良好的效果，并可能为有严重内部瘢痕形成风险的患者提供新的护理标准。该项目旨在开发一种可植入的屏障膜，以减少腹部手术后体内的瘢痕形成。目前传统的想法在生物材料的选择减少疤痕的屏障膜主要依赖于可吸收的材料。然而，这些防粘连膜的性能不足以用于严重粘连病例或腹腔镜手术。在该间隙中实施永久性屏障源于用于修补腹壁和骨盆疝的不可吸收合成补片的开发。此外，永久性膜的非降解特性确保了对表面形貌的长期控制，这已被证明在细胞粘附中起着重要作用。该项目的目标是评价在内部组织表面愈合过程中保持极其光滑、轻度疏水表面的不可吸收屏障。利用已建立的手术粘连腹部模型进行的12周确定性动物（家兔）研究将确定与对照组和市售产品相比，申报器械减少手术粘连形成的有效性。如果成功，结果将影响未来抗粘连，抗瘢痕形成和其他植入物的材料成分的决定，以及更好地了解内部伤口愈合途径

Phase I project is to improve the quality of care for patients who suffer from internalscarring triggered by abdominal surgery. Patients with severe scar formation often require afollow-up surgical procedure called adhesiolysis. Adhesiolysis is performed to cut away theinternal scars that have bridged different organs or caused intestinal obstructions. Annually,540,000 adhesiolysis procedures are performed in the US. These secondary surgicalprocedures can also cause additional scar formation resulting in cycles of repeat procedures.While current barrier products reduce the severity of internal scarring by 51%, they all degradeafter a few weeks. Furthermore, none are approved for use during laparoscopic procedures, apreferred technique for adhesiolysis. Traditionally, products used for scar reduction have beenmade from materials that degrade. In contrast, the proposed device is made from a nondegradingmaterial that has been safely used in the body for the past 40 years. This strongermaterial enables laparoscopic use and ensures separation of internal organs. As such, thisproposed device has shown promising results in pilot studies and could lead to a new standardof care for patients at risk for severe internal scar formation.The proposed project aims to develop an implantable barrier film to reduce scarformation inside the body after abdominal surgery. Current conventional thinking in biomaterialselection for scar reducing barrier films has relied primarily on resorbable materials. However,these barriers do not perform well enough to be utilized in severe adhesion cases norlaparoscopic procedures. The implementation of a permanent barrier in this space stems fromthe development of non-resorbable synthetic meshes for the repair of abdominal and pelvichernias. Furthermore, the non-degrading property of the permanent film ensures long-termcontrol over the surface topography, which has been shown to play a substantial role in celladhesion. The project goals are to evaluate a non-resorbable barrier that maintains anextremely smooth, mildly hydrophobic surface in the healing process of internal tissue surfaces.A twelve week definitive animal (rabbit) study utilizing an established surgical adhesionabdominal model will determine the efficacy of the proposed device to reduce surgical adhesionformation as compared to a control group and a commercially available product. If successful,the results will influence decisions concerning material composition for future anti-adhesion,anti-scarring, and other implants in addition to providing a better understanding of internalwound healing pathways