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

该小型企业创新研究（SBIR）第二阶段项目将继续开发防止内部组织附着的不可吸收手术薄膜。申报器械将改善心胸或神经外科手术引发内部组织附着患者的术后结局。接受手术的患者由于手术干预造成的创伤而有发生不必要的组织附着的风险。这种组织附着可能导致严重的并发症，并增加术后护理的负担，从而导致住院时间延长、再次入院以及发病率和死亡率增加等额外支出。此外，不期望的组织附着可能在必要时再次手术时阻塞手术野。手术相关的组织附着是许多领域中的许多外科手术中的问题。然而，心胸外科和神经外科手术往往比胃肠道或妇科手术更复杂，这使得任何并发症对提供者、付款人和患者来说都更加昂贵和危险。此外，心脏或神经脊柱病例的再次手术非常困难，这强调了更迫切地需要有效的解决方案来预防这种疾病。在心胸外科和神经外科手术中，一种能够有效防止不良组织附着并为外科医生提供清晰手术野和视野平面的产品是非常理想的。拟议项目将进行额外的临床前工作，以提交心胸外科适应症的监管申请，并在神经外科领域进行额外的验证。在I期IB研究期间完成的阳性动物研究揭示了Sintact薄膜的能力？以减少组织附着并在再次进入或再次手术时提供清晰的视野。初始阶段II工作将检查扩大某些制造和生产过程的可行性，从而获得将接受无菌性、安全性、动物、生物相容性和机械试验的临床级产品。本试验将直接与同品种或等同批准医疗器械进行比较。结果需要显示Sintact薄膜的等同性？在所有测试指标中与同品种器械相比。额外的第二阶段工作将进一步验证Sintact薄膜？用于神经学适应症。将完成一项更大规模的确定性神经学研究，以解决Sintact Film？to be deployed部署effectively有效in a neurological神经setting设置.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，则不可吸收产品可能是这些领域的有效对策的含义将改变该领域的当前方法。

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.