Nature-inspired Aqueous Biodegradable Adhesives for Abdominoplasty

用于腹部整形术的受自然启发的水性可生物降解粘合剂

• 批准号: 10080783
• 负责人: Chao Liu
• 金额: $ 25.2万
• 依托单位: ALEO BME, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-03 至 2022-09-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10080783
• 关键词: Abdomen; Address; Adherence; Adhesions; Adhesives; Adoption; Adverse effects; Animal Model; Binding; Biological; Biomimetics; Biopolymers; Cells; Clinical; Complication; Cosmetics; Cyanoacrylates; Dangerousness; Dermabond; Development; Domestic Pig; Elastic Tissue; Environment; Esthetics; Evaluation; Fibrin; Fibrin Tissue Adhesive; Formulation; Glues; Health Care Costs; Hedera helix; Immobilization; In Vitro; Incidence; Industry; Inflammation; Lead; Life; Modeling; Nature; Operative Surgical Procedures; Outcome; Patients; Penetration; Performance; Pharmacopoeias; Phase; Plants; Poison; Polyurethanes; Postoperative Period; Prevention; Procedures; Property; Protocols documentation; Reporting; Sclerosing Agents; Seroma; Shear Strength; Small Business Technology Transfer Research; Suction; Surface; Surgical Wound Infection; Surgical incisions; Swelling; Talc; Thrombin; Time; Tissue Adhesives; Tissues; Trees; United States; aqueous; cohesion; crosslink; cytotoxicity; in vivo; microbial; nanoparticle; particle; pre-clinical; prevent; theories; waterborne

Project Summary Seroma is the most common adverse effect of many surgical procedures and is estimated to occur in up to half of all abdominoplasties. Because abdominoplasty is one of the most commonly performed aesthetic procedures in the United States (150,000/year) seroma formation is a major concern. Problems related to seroma accumulation include patient discomfort, incisional disruption and surgical site infection. These problems lead to additional undesirable procedures, diminish cosmetic outcomes and significantly escalate healthcare costs. Various strategies have been utilized to mitigate postoperative seroma occurrence including surgical approach, talc instillation, closed suction drains, immobilization, fibrin/thrombin sprays, compression, and sclerosants. All of the approaches seek to obliterate the dead space by facilitating the re-adherence of disrupted tissue planes. Currently available commercial adhesives include fibrin glues and biopolymers, such as BioGlue®/Tisseel® and TissuGlu®, respectively. These products are limited by their poor performance in aqueous environments, weak adhesion on wet tissues, short degradation time, dangerously high swelling ratios, and/or cytotoxicity due to toxic chemical crosslinking for adhesion. Clinical outcomes are often unsatisfactory and post-operative seroma formation is common even when the current adhesives are used as an adjunct to drains. The Objective of this STTR Phase I proposal is to develop Aleo BME’s proprietary super-strong and elastic biphasic glue (BP Glue) for the prevention of post-operative seroma following abdominoplasty. The novelty of BP Glue lies in the adoption of a unique adhesion mechanism that combines a plant-inspired bioadhesion strategy and particle packing theory borrowed from the cement industry for the development of an aqueous biomimetic wet tissue adhesive for seroma control in abdominoplasty. The scientific premise of the proposal is as follows; 1) BP Glue is the first aqueous super-strong elastic tissue adhesive to achieve equivalent shear strengths (80 KPa) to Dermabond® (cyanoacrylate) and TissuGlu® through physical bonding. No toxic chemical crosslinking is involved in BP Glue adhesion; 2) BP Glue is effective to prevent seroma formation in a preclinical animal model, and 3) BP Glue adhesion mechanism simulates that of English-Ivy under which nanoparticles secreted by English-Ivy are ionically crosslinked to form an inter-locking capable of binding to rough surfaces, such as buildings, trees or biological tissues in combination with that of particle packing theory under which compositing particles with optimal size difference maximizes the cohesive strength of the resultant composite materials. The expected outcome of this proposal is that we will develop a new fully synthetic, bioinspired, elastic, and super- strong biodegradable aqueous adhesive sealant, BP Glue with superior physiochemical properties over the existing adhesives to address the challenging clinical problems in the management of seroma prevention post- abdominoplasty.

项目摘要 血清瘤是许多手术程序中最常见的不良反应，估计最多发生在一半中 在所有腹部塑料中。因为腹部成形术是最常见的美学程序之一 在美国（150,000/年），血清形成是一个主要问题。与血清有关的问题 累积包括患者不适，切口干扰和手术部位感染。这些问题导致 对于其他不良程序，化妆品的结果降低并大大升级了医疗费用。 已经利用各种策略来减轻术后血清瘤的发生，包括手术方法， 滑石粉插入，封闭任务排水，固定，纤维蛋白/凝血酶喷雾剂，压缩和硬化剂。全部 在这些方法中，试图通过支持破坏的组织平面的重新遵守来消除死亡空间。 目前可用的商业粘合剂包括纤维蛋白胶和生物聚合物，例如Bioglue®/Tisseel®和 Tissuglu®分别。这些产品受到在水性环境中性能差的限制，弱 湿提醒的粘附，较短的降解时间，危险的高肿胀比和/或细胞毒性是有毒的 化学交联广告。临床结局通常不令人满意和术后血清瘤 即使当前的粘合剂用作排水的辅助，形成也很常见。这个目的 STTR I期建议是开发Aleo BME的专有超肌和弹性双相胶（BP Glue） 用于预防腹部成形术后术后血清瘤。 BP胶的新颖性在于 采用独特的粘附机制，结合了植物启发的生物粘附策略和粒子 从水泥行业借来的包装理论以开发水性仿生湿组织 肌肉成形术中血清瘤控制的粘合剂。该提案的科学前提如下； 1）BP胶 是第一个水性超弹性弹性组织粘合剂以达到相同的剪切强度（80 kPa） 通过物理键合到Dermabond®（氰基丙烯酸酯）和Tissuglu®。无毒化学交联 参与BP胶水粘附； 2）BP胶有效防止临床前动物中的血清瘤形成 模型和3）BP胶水粘附机制模拟了英文ivy的纳米颗粒的分泌 通过英语 - 意志在离子上交联，形成一种锁骨，能够与粗糙表面结合，例如 建筑物，树木或生物组织与颗粒堆积理论的结合下 具有最佳尺寸差异的颗粒可最大化所得复合材料的内聚强度。这 该提案的预期结果是，我们将开发一种全面的完全合成，生物启发，弹性和超级 - 强可生物降解的水性粘合剂密封胶，BP胶具有优质的理化特性 现有的遵守解决方案的挑战临床问题 腹部成形术。