Tear-Resistant and Elastic Tissue Adhesive for Craniofacial Applications

适用于颅面应用的抗撕裂弹性组织粘合剂

• 批准号: 8393259
• 负责人: Silvia D Luebben
• 金额: $ 16.2万
• 依托单位: TDA RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8393259
• 关键词: Adhesions; Adhesives; Anti-Bacterial Agents; Bacteria; Biodegradation; Blood; Burn injury; Characteristics; Cicatrix; Cosmetics; Cyanoacrylates; Dermal; Drug Formulations; Elastic Tissue; Elasticity; Equipment and Supplies; Ethylene Glycols; Evaluation; Family suidae; Film; Formaldehyde; Genetic; Glass; Glues; Glycols; Government; Guidelines; Hematological Disease; Immobilization; In Vitro; Inflammation; Kinetics; Laceration; Left; Length; Letters; Link; Liquid substance; Local anesthesia; Measures; Mechanics; Medical; Methods; Minor; Modeling; Molecular Weight; Mono-S; Movement; Nature; Needles; Needlestick Injuries; Operative Surgical Procedures; Outcome; Patients; Performance; Persons; Phase; Polymers; Procedures; Process; Property; Propylene Glycols; Randomized Controlled Clinical Trials; Research; Resistance; Risk; Site; Skin; Surgical incisions; Surgical sutures; Surveys; Tensile Strength; Tissue Adhesives; Tissues; Toxic effect; United States Food and Drug Administration; United States National Institutes of Health; Visit; Water; Wound Healing; antimicrobial; biomaterial compatibility; clinical application; commercialization; craniofacial; crosslink; cytotoxicity; density; ethylene glycol; flexibility; follow-up; hydrophilicity; improved; in vivo; monomer; novel; pathogen; performance tests; polymerization; repaired; research study; skin irritation; success; transmission process; wound

DESCRIPTION (provided by applicant): Alkyl 2-cyanoacrylates have been used as surgical glues and liquid band aids for years. Current cyanoacrylates have been approved by the Food and Drug Administration (FDA) to close incised skin, repair minor abrasions, and are used as a barrier against certain pathogens. Unfortunately, because of their limited tensile and tear strengths these adhesives cannot be used to repair deep dermal cuts or to close wounds that are under tensions unless sutures and/or immobilization are also used. Finally they cannot be used to cover large abrasions, wounds or burns because they would crack during body movement. In this project TDA Research, Inc. (TDA), Golden, CO, will develop novel tissue adhesives that are tear resistant and elastic but will retain the good adhesive properties, fast kinetics of cure, good handling characteristics and low toxicity of current cyanoacrylates. These novel adhesives will allow medical professional to expand the clinical applications of tissues adhesives to more challenging cases. PUBLIC HEALTH RELEVANCE: Each year medical professionals close between 26 and 90 million incisions and lacerations in the USA. Traditionally all these procedures were performed using sutures and staples. In recent years an increasing number of patients are being treated with tissue adhesives, which are quicker and easier to apply than sutures and have a high success rate (the bond strength at 7 days is comparable to that of a 5-0 suture). Current tissue adhesives offer advantages to patients, doctors, and paying parties. Compared to sutures they provide faster wound closure and procedures, they reduce the need for surgical supplies and equipment, give better cosmetic outcomes, reduce patient discomfort and hitching at wound site, and provide a good antibacterial barrier. The use of tissue adhesives in place of sutures also eliminates the need for local anesthesia and follow-up visits to remove the stiches when non-biodegradable sutures are used. Finally avoiding needle handling eliminates the risk of needle stick injuries, which is important in minimizing the risk of transmission of blood diseases. Unfortunately the low tensile strength of current tissue adhesives limits their use to small cuts and abrasions and sutures are still significantly better than tissue adhesives for minimizing dehiscence. In this research TDA will develop tissue adhesives that have the improved tensile strength and tear resistance needed to repair larger wounds or wounds under tension and for covering larger skin abrasions.

描述（由申请人提供）：2-氰基丙烯酸烷基酯多年来一直被用作手术胶水和液体创可贴。目前的氰基丙烯酸酯已获得美国食品和药物管理局 (FDA) 的批准，可用于闭合切开的皮肤、修复轻微擦伤，并用作抵抗某些病原体的屏障。不幸的是，由于其有限的拉伸和撕裂强度，这些粘合剂不能用于修复深层真皮切口或闭合处于张力下的伤口，除非还使用缝合和/或固定。最后，它们不能用于覆盖大面积擦伤、伤口或烧伤，因为它们会在身体运动过程中破裂。在该项目中，位于科罗拉多州戈尔登的 TDA Research, Inc. (TDA) 将开发新型组织粘合剂，该粘合剂具有抗撕裂性和弹性，但仍保留了现有氰基丙烯酸酯的良好粘合性能、快速固化动力学、良好的操作特性和低毒性。这些新型粘合剂将使医疗专业人员能够将组织粘合剂的临床应用扩展到更具挑战性的病例。 公共健康相关性：每年，美国医疗专业人员会缝合 26 至 9000 万个切口和撕裂伤。传统上，所有这些手术都是使用缝合线和钉书钉进行的。近年来，越来越多的患者使用组织粘合剂进行治疗，这种粘合剂比缝线使用更快、更容易，并且成功率很高（7 天的粘合强度与 5-0 缝合线相当）。目前的组织粘合剂为患者、医生和付费方提供了优势。与缝合线相比，它们提供更快的伤口闭合和手术速度，减少对手术用品和设备的需求，提供更好的美容效果，减少患者不适和伤口部位的束缚，并提供良好的抗菌屏障。使用组织粘合剂代替缝线还消除了使用不可生物降解缝线时进行局部麻醉和后续拆线的需要。最后，避免针头操作可以消除针刺伤害的风险，这对于最大限度地降低血液疾病传播的风险非常重要。 不幸的是，当前组织粘合剂的低拉伸强度限制了它们在小切口和擦伤中的使用，并且缝合线在最大限度地减少开裂方面仍然明显优于组织粘合剂。在这项研究中，TDA 将开发具有更高拉伸强度和抗撕裂性的组织粘合剂，以修复较大的伤口或张力下的伤口以及覆盖较大的皮肤擦伤。