Sprayable Surgical Adhesive for Seroma Prevention

用于预防血清肿的可喷涂手术粘合剂

• 批准号: 7480136
• 负责人: Eric J. Beckman
• 金额: $ 91.73万
• 依托单位: COHERA MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7480136
• 关键词: Adhesives; American; Amino Acids; Animal Model; Benign; Biocompatible; Biological; Characteristics; Chemicals; Chemistry; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Closure; Complication; Custom; Data; Device Designs; Device or Instrument Development; Devices; Esthetics; Fibrin Tissue Adhesive; Glues; Goals; Guanosine Monophosphate; Healed; Human; Infection; Label; Life; Liquid substance; Marketing; Molds; Molecular; Mutagenicity Tests; Numbers; Object Attachment; Operative Surgical Procedures; Patients; Phase; Placement; Plastic Surgical Procedures; Polyurethanes; Positioning Attribute; Prevention; Price; Procedures; Production; Protocols documentation; Public Health; Rate; Recovery; Research Personnel; Risk; Running; Safety; Seroma; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Societies; Speed; Sterilization for infection control; Surface; Surgeon; Surgical Flaps; Surgical complication; Surgical sutures; Syringes; System; Testing; Time; Tissue Adhesives; Tissues; Toxic effect; United States Food and Drug Administration; Visit; base; biomaterial compatibility; design; follow-up; healing; innovation; novel; pre-clinical; prevent; prototype; sample fixation; success; sugar; wound

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.

描述(申请人提供)：该项目的长期目标是创造一种可喷雾的手术粘合剂，以满足外科手术对粘合平面组织瓣的强力、易用粘合剂的需要。这种新型粘合剂将通过消除伤口中的死腔和保持组织处于自然愈合的位置来减少手术后液体的积累。浆膜瘤形成是最常见的术后并发症之一，在某些外科手术中发生的比例高达50%。传统的伤口闭合方法，如缝合，提供点对点固定，这不足以完全粘连平面表面。外科医生需要可以完全粘合平面组织瓣而不需要与组织直接接触的喷雾胶。在公司的第一阶段SBIR项目中，科赫拉成功地展示了开发一种可再吸收、可喷涂的粘合剂TIsGlu“的可行性，以及喷雾输送装置的功能原型。科赫拉建议通过动物模型和人类临床试验证明其新产品在生物相容性和减少术后液体积聚方面是有效的，从而检验其新产品将满足FDA对安全性和有效性的要求的假设。在拟议的第二阶段SBIR项目中，我们将实现以下具体目标：1)完成输送设备的开发。主要目标包括a)为设备部件准备定制的成型设计，b)建立粘合剂和动员剂的填充程序，c)制造和组装第一批100个原型设备，以及d)启动交付设备中产品的保质期和稳定性测试。2)完成向FDA提交的研究设备豁免(IDE)的临床前测试。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兼容性和遗传毒性测试，以及c)在可接受的动物模型中完成疗效研究。3)建立胶粘剂的GMP生产、包装和灭菌制度。主要目标包括a)生成生产规程和批量释放标准，b)建立灭菌规程以及包装和标签要求，以及c)完成第一次人类临床试验的中试规模生产批次。4)对人类患者进行初步临床研究(可行性阶段)，以支持上市前批准(PMA)提交。主要目标包括a)完成拟议的临床试验设计以供FDA审查，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：浆膜瘤形成是最常见的术后并发症之一，在某些外科手术中发生的比例高达50%。该项目的长期目标是创造一种可喷洒的手术粘合剂，通过保持组织处于自然愈合的位置来减少手术后的液体积累。使用粘合剂来防止血清形成将减少患者的不适，降低感染的风险，并加快患者的康复。