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 血清肿是许多外科手术中最常见的不良反应，据估计， 所有的腹部整形手术。因为腹部整形术是最常见的美容手术之一 在美国（150，000/年），血清肿形成是一个主要问题。血清肿相关问题 累积包括患者不适、切口破裂和手术部位感染。这些问题导致 附加的不希望的程序，减少美容效果和显著增加医疗保健费用。 已采用各种策略来减轻术后血清肿的发生，包括手术入路， 滑石粉滴注、封闭式吸引引流、固定、纤维蛋白/凝血酶喷雾、压迫和硬化剂。所有 这些方法的目的是通过促进破裂组织平面的重新粘附来消除死腔。 目前可获得的商业粘合剂包括纤维蛋白胶和生物聚合物，例如BioGlue®/Tisseel®和BioGlue®/Tisseel®。 TissuGlu®。这些产品受限于它们在水性环境中的差性能、弱的耐腐蚀性和耐腐蚀性。 在湿组织上的粘附、短降解时间、危险的高溶胀比和/或由于毒性引起的细胞毒性。 化学交联用于粘合。临床结果往往不令人满意，术后血清肿 即使当目前的粘合剂用作排水管的辅助剂时，也是常见的。的目的 STTR第一阶段提案是开发Aleo BME专有的超强弹性双相胶（BP胶） 用于预防腹部整形术后的术后血清肿。BP Glue的新颖之处在于 采用独特的粘附机制，结合了植物启发的生物粘附策略和颗粒 从水泥工业中借鉴包装理论，用于开发水性仿生湿巾 用于腹部整形术中控制血清肿的粘合剂。该建议的科学前提如下：1）BP胶 是第一种达到同等剪切强度（80 KPa）的水性超强弹性组织粘合剂 Dermabond®（氰基丙烯酸酯）和TissuGlu®通过物理粘合。无毒性化学交联 参与BP胶粘附; 2）BP胶可有效预防临床前动物血清肿形成 BP Glue粘附机制模拟English-Ivy粘附机制，在该粘附机制下纳米颗粒分泌 常春藤是离子交联的，形成能够结合到粗糙表面的互锁，例如 建筑物、树木或生物组织与颗粒堆积理论相结合， 具有最佳尺寸差的颗粒使所得复合材料的内聚强度最大化。的 这一建议的预期结果是，我们将开发一种新的全合成，生物启发，弹性，和超级， 强力可生物降解水性粘合密封剂，BP胶具有上级的理化性能， 现有的粘合剂，以解决具有挑战性的临床问题，在管理血清肿预防后， 腹部整形术