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: 10435716
• 负责人: Michael Ray DeLong
• 金额: $ 25.45万
• 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 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10435716
• 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; Dermal; Devices; Distant; Distress; Effectiveness; Esthetics; Evaluation; Excision; Goals; Gold; Healthcare Systems; Implant; Implantation procedure; Individual; Internal Breast Prosthesis; Investigation; Label; Literature; Location; Mammaplasty; Manufacturer Name; 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; 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; base; breast surgery; cohort; comparative; design; feasibility trial; hospital readmission; implantable device; instrument; malignant breast neoplasm; medical food; meetings; off-label use; operation; 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.

项目总结/摘要 八分之一的女性在一生中会患上乳腺癌，造成身体和心理上的伤害。 由于侵入性治疗造成的创伤和与乳房切除相关的痛苦。乳房再造 乳房切除术后已成为许多妇女恢复心理健康的关键程序， 种植体重建是最常见的方法。近10万名患者接受重建 在美国每年都有隆胸手术 外科网片装置，特别是脱细胞真皮基质，现在被大多数人标签外使用。 进行乳房假体重建的重建外科医生。在过去的十年里，外科医生 主张从肌下重建（将植入物置于胸肌下）过渡 到胸肌前（放置在胸肌上方），并且通常认为补片对于该手术是必要的。 FDA尚未批准外科补片用于任何解剖位置的乳房重建。这些 补片器械与阴道补片相似，被视为III类医疗器械，FDA最近优先考虑 在2019年的一次小组会议上对这些产品进行了评估。 尚未成功进行I级随机试验以确定实际风险和获益 乳房再造中的网状装置。虽然现有的数据主要是回顾性的， 关于肌下重建的观察性、多项小型研究和荟萃分析发现， 使用外科补片的并发症发生率和患者满意度无任何受益。实践趋势有 偏离了这一结论，很大程度上与现有研究的低质量有关。随着外科医生的转变 对于前胸肌平面，补片制造商得出结论，不可能进行I级研究 因为很少有外科医生在没有补片的情况下进行胸肌前重建 援助.尽管如此，一些整形外科医生质疑这一假设，并支持 随机化研究，特别是因为补片在既往研究中与较高的并发症相关， 肌肉下平面，并且是医疗保健系统的昂贵负担（每个乳房高达20，000美元 取决于产品）。现在严格评估这些植入的网状装置是关键和可行的 用于脆弱的乳腺癌患者。这项研究首次提出 在两阶段假体胸大肌前乳房再造中使用补片辅助的随机、多中心试验， 在各大制造商中。重要的是，这将是第一项包括对照队列的研究， 接受补片，并将符合FDA法规，包括已批准的试验用器械豁免。 目的是证明这种研究的可行性，并为评估提供高水平的数据 这些产品的安全性和有效性，以造福妇女的公共健康。