Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Safety - Major Complications
研究概览
简要总结
Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.
详细描述
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 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. This study proposes a pilot study as the first ever randomized, multi-center trial for mesh assistance in two-stage prosthetic pre-pectoral breast reconstruction, across the major manufacturers. 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will blinded to whether they receive ADM products during their reconstruction.
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
- •Prophylactic and oncologic mastectomies are both acceptable
- •Nipple sparing and skin sparing mastectomy techniques are both acceptable
排除标准
- •Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
- •Bilateral reconstruction patients undergoing contralateral submuscular reconstruction
- •Direct-to-implant reconstruction
- •Pregnancy
- •Delayed reconstruction
研究组 & 干预措施
Acellular Dermal Matrix
Patients will receive ADM during their initial tissue expander placement.
干预措施: Acellular Dermal Matrix (Device)
Control
Patients will not receive ADM during their initial tissue expander placement.
干预措施: Reconstruction without ADM (Procedure)
结局指标
主要结局
Safety - Major Complications
时间窗: 2 years
Relative rate of major complications (requiring unplanned re-admission or re-operation)
Effectiveness - BREASTQ
时间窗: 2 years
BREAST-Q validated patient reported questionnaire to assess results of final reconstruction.
次要结局
- Capsular Contracture(2 years)
- Secondary Safety(2 years)
- Secondary Effectiveness(2 years)
研究者
Michael R. Delong
Assistant Professor-in-Residence
University of California, Los Angeles