Low-Cost Sprayable Barrier for the Prevention of Surgical Adhesions

 描述（由申请人提供）：腹腔内手术后粘连形成会造成巨大的健康风险，被认为是小肠梗阻和女性不孕症的主要原因。防止这些粘连的方法目前限于难以放置的阻挡膜，并且通常限于用于防止粘连到手术切口，从而使大部分腹部内容物不受保护。该计划旨在开发一种低成本、可喷涂的屏障，该屏障将在腹腔内部组织周围流动并粘附，从而为整个腹腔提供更广泛的粘连保护。由于该产品中成分的性质，拟议材料将具有生物相容性和生物降解性，因为它提供比目前市售产品更全面的保护。该计划将侧重于材料成分和输送系统的开发和表征，以创建屏障配方。然后将这些所得制剂进行一系列体外表征测试，以评估其有效地充当粘连形成屏障的能力和小动物体内功效证明。最后，最有希望的制剂将在兔的确定性临床前动物模型中进行评估。这些结果将成为产品商业化工作和提交给FDA的基础。

 DESCRIPTION (provided by applicant): Adhesion formation after intra-abdominal surgery poses a huge health risk, cited as a leading cause of small bowel obstruction and female infertility. Methods to prevent these adhesions are currently limited to barrier films which are difficult to place and are often restricted to use preventing adhesions to the surgical incision sie, leaving the bulk of the abdominal contents unprotected. This program is for the development of a low-cost, sprayable barrier that will flow around and adhere to the internal tissues of the abdominal cavity, providing broader protection from adhesions throughout the abdominal cavity. Because of the nature of the components in this product, the proposed material will be biocompatible and biodegradable as it provides more complete protection than is available from currently marketed products. This program will focus on the development and characterization of the material components and delivery system to create the barrier formulations. These resultant formulations will then undergo a series of in vitro characterization tests to assess thei ability to effectively serve as a barrier to adhesion formation and small animal in vivo demonstration of efficacy. Finally, the most promising formulations will undergo assessment in a definitive preclinical animal model in rabbits. The results will be the basis for product commercialization efforts and submission to the FDA.