Sprayable Surgical Adhesive for Seroma Prevention

描述（由申请人提供）：该项目的长期目标是创造一种可喷涂的外科粘合剂，以满足外科对牢固，易于使用的粘合剂粘附平面组织皮瓣的需求。这种新型胶粘剂通过消除伤口中的死区，使组织保持原位，使其自然愈合，从而减少手术后的液体积聚。血清肿形成是最常见的术后并发症之一，在某些外科手术中发生率高达50%。传统的伤口闭合方法如缝合线提供点对点固定，不足以完全粘附平面。外科医生需要可喷涂的胶水，它可以完全粘附在组织的平面皮瓣上，而不需要直接接触组织。在公司的一期SBIR项目中，Cohera成功地展示了开发可吸收、可喷涂粘合剂TissuGlu的可行性，以及喷雾输送装置的功能原型。Cohera建议通过在动物模型和人体临床试验中证明其生物相容性和减少手术后液体积聚的有效性，来验证其新产品将满足FDA安全性和有效性要求的假设。在拟议的第二期SBIR项目中，我们将实现以下具体目标：1)完成交付装置的开发。主要目标包括a)准备设备组件的定制成型设计，b)建立粘合剂和动员剂的填充程序，c)制造和组装100个原型设备的初始运行，d)启动交付设备中产品的保质期和稳定性测试。2)完成临床前试验，向FDA提交研究器械豁免（IDE）。主要目标包括a)完成粘合剂产品的特定物理和化学特性研究，b)完成粘合剂产品的生物相容性和遗传毒性测试，以及c)在可接受的动物模型中完成功效研究。3)建立胶粘剂生产、包装和灭菌的GMP。主要目标包括a)制定生产方案和批放行标准，b)建立灭菌方案和包装和标签要求，以及c)完成首次人体临床试验的中试规模生产批次。4)在人类患者中进行初步临床研究（可行性阶段），以支持上市前批准（PMA）的提交。主要目标包括a)完成FDA审查的临床试验设计，b)向FDA提交完整的IDE申请，c)在一小部分患者中完成可行性临床试验。公共卫生相关性：血肿形成是最常见的术后并发症之一，在某些外科手术中发生率高达50%。该项目的长期目标是创造一种可喷涂的手术胶粘剂，通过保持组织在自然愈合的位置来减少手术后的液体积聚。使用粘接剂防止血肿形成将减少患者的不适感，降低感染风险，并加快患者康复。

DESCRIPTION (provided by applicant): The long-term goal of this project is to create a sprayable surgical adhesive which would satisfy the surgical need for a strong, easy-to-use adhesive to adhere planar flaps of tissue. This novel adhesive will reduce fluid accumulation after surgery by eliminating dead space in the wound and maintaining tissues in position for natural healing to occur. Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. Traditional wound closure approaches such as sutures provide point-to-point fixation, which is inadequate to fully adhere planar surfaces. Surgeons need sprayable glue that can fully adhere planar flaps of tissue without requiring direct contact with the tissue. During the Company's Phase I SBIR project, Cohera successfully demonstrated the feasibility of developing a resorbable, sprayable adhesive, TissuGlu", as well as a functional prototype of the spray delivery device. Cohera proposes to test the hypothesis that its novel product will meet the FDA requirements for safety and efficacy, by demonstrating that it is biocompatible and effective at reducing fluid accumulation after surgery in both animal models and human clinical trials. During the proposed Phase II SBIR project, we will achieve the following Specific Aims: 1) Finalize delivery device development. Primary goals include a) preparing custom molding designs for device components, b) establishing filling procedures for adhesive and mobilizing agent, c) manufacturing and assembling an initial run of 100 prototype devices, and d) initiating shelf life and stability testing of product in delivery device. 2) Complete pre-clinical testing for Investigational Device Exemption (IDE) submission to the FDA. Primary goals include a) completing specific physical and chemical characterization studies on adhesive product, b) completing biocompatibility and genotoxicity testing on adhesive product, and c) completing efficacy studies in an acceptable animal model. 3) Establish GMP manufacturing, packaging, and sterilization of adhesive. Primary goals include a) generating manufacturing protocols and batch release criteria, b) establishing sterilization protocols and packaging and labeling requirements, and c) completing pilot scale production batch for first human clinical trials. 4) Perform initial clinical study (feasibility phase) in human patients to support Pre-market Approval (PMA) submission. Primary goals include a) completing proposed clinical trial design for review by FDA, b) submitting a completed IDE application to the FDA, c) completing the feasibility clinical trial in a small set of patients. PUBLIC HEALTH RELEVANCE: Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. The long term goal of this project is to create a sprayable surgical adhesive that will reduce fluid accumulation after surgery by maintaining tissues in position for natural healing to occur. The use of the adhesive to prevent seroma formation will reduce patient discomfort, decrease risk of infection, and speed patient recovery.