SBIR Phase II: Development of a Barrier Film to Prevent Post-operative Internal Scarring

这个小企业创新研究（SBIR）二期项目将继续开发一种不可吸收的手术膜，防止内部组织附着。该装置将改善由心胸外科或神经外科手术引发的内部组织附着患者的术后预后。接受手术的患者由于手术干预造成的创伤而有发展不需要的组织附着的风险。这种组织附着可导致严重的并发症，并增加术后护理负担，导致住院时间延长、再入院以及发病率和死亡率增加等额外支出。此外，当需要再次手术时，不良的组织附着会阻碍手术视野。外科相关的组织附着是许多领域的外科手术中的一个问题。然而，心胸和神经系统手术通常比胃肠或妇科手术更复杂，这使得任何并发症对提供者、付款人和患者来说都更昂贵和有风险。此外，心脏或神经脊柱病例的再手术极其困难，这强调了迫切需要有效的解决方案来预防这种疾病。一种能够有效防止不良组织附着并为外科医生提供清晰的手术视野和平面视野的产品在心胸外科和神经外科手术中都是非常理想的。拟议的项目将进行额外的临床前工作，以提交心胸适应症的监管申请，并在神经学领域进行额外的验证。在I期和IB阶段完成的阳性动物研究显示了sinactfilm的能力。减少组织附着，并提供一个清晰的视野，再入或再手术。最初的II期工作将审查扩大某些制造和生产工艺的可行性，从而产生临床级产品，该产品将经过无菌、安全性、动物、生物相容性和机械测试。该测试将直接与谓词或同等批准的医疗设备进行比较。结果将需要显示等效的sinactfilm ？到谓词设备的所有测试指标。第二阶段的额外工作将进一步验证sinactfilm ？用于神经学适应症。一项更大的神经学研究将完成，以解决sinactfilm的能力？能有效地应用于神经系统。这项研究的积极结果将为寻求扩大适应症和额外的市场机会提供基础。如果成功，不可吸收产品可以成为这些领域的有效对策的含义将改变该领域目前的方法。

This Small Business Innovation Research (SBIR) Phase II Project will continue development of a non-resorbable surgical film which prevents internal tissue-attachment. The proposed device will improve post-surgical outcomes from patients who suffer from internal tissue-attachment triggered by cardiothoracic or neurological surgery. Patients who undergo surgery are at risk for developing unwanted tissue-attachment due to trauma as a result of surgical intervention. This tissue-attachment can lead to severe complications and increase the burden of post-operative care resulting additional expenditures through extended hospital stays, readmissions, and increased morbidity and mortality rates. In addition, undesirable tissue attachment can obstruct the surgical field upon re-operation when necessary. Surgical related tissue-attachment is a problem amongst many surgical procedures in a number of areas. However, cardiothoracic and neurological procedures are often more complicated than gastrointestinal or gynecologic procedures, making any complications more expensive and risky to providers, payers and patients. Additionally, re-operations in cardiac or neuro-spine cases are extremely difficult, which underscore the need for an effective solutions to prevent this malady even more urgent. A product that can effectively prevent undesirable tissue-attachment and provide the surgeon with a clear surgical field and plane of view would be highly desirable in both cardio-thoracic and neurological surgery.The proposed project will conduct additional pre-clinical work leading to a regulatory submission for a cardio-thoracic indication and additional validation within the neurological field. Positive animal studies completed during Phase I & IB efforts revealed the capacity of the Sintact Film? to reduce tissue attachment and provide for a clear field of view upon re-entry or re-operation. Initial Phase II work will examine the feasibility of scaling-up certain manufacturing and production processes resulting in a clinical grade product which will undergo sterility, safety, animal, biocompatibility, and mechanical testing. This testing will be compared directly to a predicate or equivalent approved medical device. Results will need to show equivalency of the Sintact Film? to the predicate device across all testing metrics. Additional Phase II work will enable further validation of the Sintact Film? for neurological indications. A larger definitive neurological study will be completed to address the capability of the Sintact Film? to be deployed effectively in a neurological setting. Positive results from this study will provide a basis for pursuing expanded indications and additional market opportunities. If successful the implications that a non-resorbable product can be an effective countermeasure in these areas would alter the current methodology in the field.