Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

胸肌重建前网片的随机可行性试验

• 批准号: 10553174
• 负责人: Michael Ray DeLong
• 金额: $ 17.52万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10553174
• 关键词: Address; Adverse event; Advisory Committees; Advocate; Anatomy; Benefits and Risks; Breast; Breast Cancer Patient; Cancer Patient; Chest; Chest wall structure; Client satisfaction; Complication; Consent; Control Groups; Data; Dedications; Dermal; Devices; Distant; Distress; Effectiveness; Esthetics; Evaluation; Excision; Goals; Healthcare Systems; Implant; Implantation procedure; Individual; Internal Breast Prosthesis; Label; Literature; Location; Mammaplasty; Manufacturer; Mastectomy; Measures; Medical Device; Meta-Analysis; Modernization; Multicenter Trials; Muscle; Outcome; Patients; Pectoral; Pectoralis Muscles; Perioperative; Pilot Projects; Plastic Surgeon; Plastic Surgical Procedures; Positioning Attribute; Procedures; Prosthesis; Protocols documentation; Public Health; Questionnaires; Randomized; Refusal to Participate; Regulation; Repeat Surgery; Research Design; Safety; Stress; Surgeon; Surgical Mesh; Tissue Expanders; United States; United States Food and Drug Administration; Vagina; Well in self; Woman; Women' s Health; arm; breast surgery; cohort; comparative; design; feasibility trial; hospital readmission; implantable device; instrument; malignant breast neoplasm; medical food; meetings; off-label use; participant enrollment; psychological trauma; randomized trial; reconstruction; safety outcomes; satisfaction; success; systematic review; trend

Project Summary/Abstract One in eight women will develop breast cancer in her lifetime, causing both physical and psychological trauma due to invasive treatments and the distress associated with removal of a breast. Breast reconstruction after mastectomy has become a critical procedure for many women to restore psychological wellbeing, with implant-based reconstruction the most common approach. Nearly 100,000 patients undergo reconstruction with implants every year in the United States. Surgical mesh devices, particularly acellular dermal matrices, are now used off-label by most reconstructive surgeons performing prosthetic breast reconstruction. In the past decade, surgeons have advocated a transition from submuscular reconstruction (placement of the implant under the pectoralis muscle) to pre-pectoral (placement above the pectoralis) and often consider mesh to be necessary for this procedure. Surgical mesh has not been approved by the FDA for breast reconstruction for either anatomic location. These mesh devices, similar to vaginal mesh, are considered Class III medical devices and FDA recently prioritized the evaluation of these products during a panel meeting in 2019. No Level I randomized trial has been successfully performed to determine the actual risks and benefits of mesh devices in breast reconstruction. Although the existing data are primarily retrospective and observational, multiple small studies and meta-analyses on submuscular reconstructions have found increased complication rates with the use of surgical mesh and no benefit in patient satisfaction. Practice trends have deviated from this conclusion, largely related to the low quality of the existing studies. As surgeons transition to the pre-pectoral plane, mesh manufacturers have concluded that it is impossible to perform a Level I study due to a perceived paucity of surgeons who would perform pre-pectoral reconstruction without their mesh assistance. Nonetheless, several plastic surgeons have questioned this assumption and are supportive of a randomized study, especially because mesh has been associated with higher complications in prior studies in the submuscular plane, and is an expensive burden on the healthcare system (up to 20,000 dollars per breast depending on the product). It is now critical and feasible to rigorously evaluate these implanted mesh devices that are being used, off-label, in vulnerable breast cancer patients. This study proposes the first ever randomized, multi-center trial for mesh assistance in two-stage prosthetic pre-pectoral breast reconstruction, across the major manufacturers. Importantly, it will be the first study to include a control cohort that does not receive mesh and will comply with FDA regulations including an approved Investigational Device Exemption. The goals are to demonstrate feasibility of such a study and to generate high level data toward the evaluation of safety and effectiveness of these products for the benefit of women’s public health.

项目摘要/摘要 八分之一的妇女一生会造成乳腺癌，导致身体和心理 由于侵入性治疗以及与乳房切除有关的困扰而引起的创伤。乳房重建 乳房切除术成为许多妇女恢复心理健康的关键程序，并通过 基于植入物的重建是最常见的方法。将近100,000名患者重建 每年在美国都有即兴。 现在，大多数标签都使用了手术网状设备，尤其是细胞皮肤材料。 重建外科医生进行假肢乳房重建。在过去的十年中，外科医生有 主张从肌肉束重建（植入胸腔下的植入物放置）过渡 前视线（位于胸大肌上方的位置），并且通常认为对于此程序是必需的。 FDA尚未批准手术网格在任何一个解剖位置进行乳房重建。这些 类似于阴道网格的网格设备被认为是III类医疗设备，而FDA最近优先考虑 在2019年的小组会议上对这些产品的评估。 尚未成功执行I级I随机试验来确定实际风险和福利 乳房重建中的网格设备。尽管现有数据是主要的回顾性，并且 观察性的，多个小型研究和对肌肉互重建的荟萃分析发现有所增加 使用手术网格的并发症发生率，患者满意度无益。练习趋势有 偏离了这一结论，与现有研究的低质量有关。作为外科医生过渡 对于前光线平面，网格制造商得出的结论是，不可能进行我研究的水平 由于认为外科医生的缺乏，他们将在没有网状的情况下进行频前重建 协助。但是，几位整形外科医生对此假设质疑，并得到了 随机研究，尤其是因为网格与先前研究的较高并发症有关 肌肉局部的飞机，是医疗保健系统上的昂贵燃烧（每乳房最高20,000美元 取决于产品）。现在，严格评估这些植入的网格设备是至关重要的且可行的 在脆弱的乳腺癌患者中使用的标签被标签使用。这项研究提出有史以来第一个 随机，多中心试验在两阶段的假肢前乳房重建中进行网格辅助试验， 在主要制造商中。重要的是，这将是首次包括一个对照组的研究 接收网格，并遵守FDA法规，包括批准的调查设备豁免。 目标是证明此类研究的可行性，并为评估生成高水平的数据 这些产品的安全性和有效性是为了使妇女的公共卫生受益。