A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 353
- 试验地点
- 2
- 主要终点
- Percentage of patients who experience major complications
研究概览
简要总结
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.
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
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 21-60 years
- •Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer
- •Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage
- •Planning to undergo nipple-sparing or skin-sparing mastectomy
- •Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion
- •Intraoperative confirmation of prepectoral plane viability by operating physician
排除标准
- •History of radiotherapy to the operative breast
- •Current smoker
- •Non-English speaking patients
- •Planning to undergo direct-to-implant reconstruction
- •Prior sternotomy
研究组 & 干预措施
Prepectoral Breast Reconstruction with ADM
干预措施: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) (Procedure)
Prepectoral Breast Reconstruction without ADM
干预措施: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM) (Procedure)
结局指标
主要结局
Percentage of patients who experience major complications
时间窗: 90 days
Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis): * Infection defined as: * Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics * Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics * Purulent drainage from the surgical site or incision * Explantation defined as the need for removal of a TE for any cause * Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication
次要结局
- Estimate rates of minor complications (specifically seroma)(90 days)