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发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。粘连松解术用于切除连接不同器官或引起肠梗阻的内部疤痕。在美国，每年进行54万例粘连松解手术。这些二次手术也会造成额外的疤痕形成，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%，但它们在几周后都会降解。此外，没有一种被批准在腹腔镜手术中使用，这是粘连溶解的首选技术。传统上，用于疤痕减少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不可降解的材料制成的，这种材料在过去的40年里一直在人体中安全使用。这种更坚固的材料可以用于腹腔镜，并确保内部器官的分离。因此，该提议的设备在初步研究中显示出有希望的结果，并可能为有严重内部瘢痕形成风险的患者提供新的标准护理。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。目前传统的生物材料选择疤痕减少屏障膜主要依赖于可吸收材料。然而，这些屏障的性能不够好，不能用于腹腔镜手术中严重粘连的病例。在这个空间中，永久性屏障的实施源于不可吸收的合成网的发展，用于修复腹部和骨盆。此外，永久膜的不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。该项目的目标是评估一种不可吸收的屏障，在内部组织表面的愈合过程中保持极其光滑、轻度疏水的表面。利用已建立的手术粘连腹腔模型进行为期12周的动物（兔）研究，将确定与对照组和市售产品相比，所建议的设备减少手术粘连形成的功效。如果成功，除了提供对内部伤口愈合途径的更好理解外，结果将影响未来抗粘连、抗瘢痕和其他植入物的材料成分的决定

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