Fibrin sutures for non-scarring wound closure

纤维蛋白缝合线用于无疤痕伤口闭合

• 批准号: 8834658
• 负责人: Adam Collette
• 金额: $ 17.9万
• 依托单位: VITATHREADS, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-12-15 至 2015-06-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8834658
• 关键词: Adverse event; Animal Model; Appearance; Area; Biocompatible Materials; Biological; Biomedical Engineering; Cells; Chronic; Cicatrix; Clinical; Cosmetic surgery; Deposition; Dermal; Dermis; Devices; Engineering; Ensure; Environment; Enzymes; Esthetic Surgery; Esthetics; Evaluation; Excision; Eye; Face; Family; Fibrin; Fibrosis; Generations; Gold; Healed; Immune response; In Situ; In Vitro; Inflammation; Inflammatory; Institutes; Keloid; Lasers; Lead; Ligation; Marketing; Marriage; Mechanics; Medical Device; Medicine; Modeling; Modification; North Carolina; Operative Surgical Procedures; Outcome; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Plasmin; Plastic Surgical Procedures; Procedures; Process; Rattus; Role; Skin Tissue; Specific qualifier value; Surgeon; Surgical incisions; Surgical sutures; Talents; Technology; Tensile Strength; Testing; Time; Tissue Engineering; Tissues; United States; Universities; Ursidae Family; Work; Wound Healing; absorption; base; commercialization; crosslink; healing; high standard; improved; in vivo; novel; polymerization; public health relevance; repaired; response; skills; success; wound

DESCRIPTION (provided by applicant): Nearly 55 million people annually undergo surgical procedures which require an incision closure. Of these patients, 40-90% of them will bear a scar as a result of this procedure, resulting from a combination of closure choice, clinician skill, and the incision itself. While typically justified by the necessity of the surgery, a Holy Grail of modrn medicine has long been scar-free wound-healing. VitaSuture Absorbable Surgical Suture, a fast-absorbing non- inflammatory suture based upon fibrin microthread technology represents a key step forward. Nowhere is the margin for success slimmer or the envelope pushed harder in this pursuit than in the field of aesthetic facial surgery. The high-visibility and high-sensitivit procedures carried out nearly 1.6 million times last year in the United States as elective procedures demand a best- possible result in every case. The current gold-standard for high-visibility incision wound closure is typically absorbable or non-absorbable suture which affords the clinician the control to precisely align and tension the wound edges for an optimal outcome. Even still, despite the talent of surgeons and current suture technology, suture-related adverse events are thought to occur in more than 3% of cases including such things as chronic fibrosis, scar deposition, inflammation, and suture extrusion. Even removal of non-absorbable sutures shortly after initial incision closure result in moderate disruption to the host environment, prolonged patient discomfort, and additional procedural time. VitaSuture Absorbable Surgical Suture, a novel fibrin microthread-based suture offer the ability to close incision wounds with a fast-absorbing surgical suture eliciting virtually no host response. The reason for VitaSuture' exceptional host compatibility is due to the use of fibrin microthreads in its construction. A component of native wound healing, fibrin is well-tolerated in vivo and is resorbed by enzymes such as plasmin naturally occurring during wound healing. This work will identify a VitaSuture configuration which is both mechanically and biologically viable as a suture product. Initial efforts will refine the mechanics of the constituent fibrin microthreads, followed by mechanical refinements to the assembled device, and concluded with mechanical and biological evaluation using the rat dermis to model incision wound healing. This proposal presents a unique marriage between the native function of a biomaterial, a novel format, and a market need driven by a team who prioritize commercialization.

描述（由申请人提供）：每年有近 5500 万人接受需要切口闭合的外科手术。在这些患者中，40-90% 的患者会因该手术而留下疤痕，这是由于闭合选择、临床医生技能和手术的综合影响造成的。 切口本身。虽然通常认为手术的必要性是合理的，但现代医学的圣杯长期以来一直是无疤痕伤口愈合。 VitaSuture 可吸收手术缝合线是一种基于纤维蛋白微线技术的快速吸收非炎症缝合线，代表着向前迈出的关键一步。在这一追求中，没有什么地方比面部美容手术领域更成功的了。去年，高可见度和高敏感度的手术在美国进行了近 160 万次，因为择期手术要求在每个病例中都获得最佳结果。当前高可见度切口伤口闭合的黄金标准通常是可吸收或不可吸收的缝合线，这使临床医生能够控制精确对齐和张紧伤口边缘，以获得最佳结果。即便如此，尽管外科医生的才华和当前的缝合技术，但据认为超过 3% 的病例会发生与缝合相关的不良事件，包括慢性纤维化、疤痕沉积、炎症和缝合线挤出等。即使在初始切口闭合后不久去除不可吸收缝线也会导致对宿主环境的中度破坏、延长患者不适以及额外的手术时间。 VitaSuture 可吸收手术缝合线是一种新型的基于纤维蛋白微线的缝合线，能够通过快速吸收的手术缝合线闭合切口伤口，几乎不会引起宿主反应。 VitaSuture 具有出色的宿主兼容性的原因在于其结构中使用了纤维蛋白微丝。纤维蛋白是自然伤口愈合的组成部分，在体内具有良好的耐受性，并且可以被伤口愈合过程中自然产生的纤溶酶等酶吸收。这项工作将确定一种 VitaSuture 配置，该配置作为缝合产品在机械和生物学上均可行。最初的工作将完善纤维蛋白微线的力学结构，然后对组装设备进行机械改进，最后使用大鼠真皮模拟切口伤口愈合进行机械和生物学评估。该提案呈现了生物材料的固有功能、新颖的形式和由优先考虑商业化的团队驱动的市场需求之间的独特结合。