NCT06027996招募中不适用
Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)
Melodi Health, Inc.20 个研究点 分布在 1 个国家目标入组 702 人开始时间: 2024年8月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 702
- 试验地点
- 20
- 主要终点
- Complications of Breast Reconstruction
研究概览
简要总结
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 22 or older at the time of enrollment.
- •Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.
- •Is able to and willing to comply with the study requirements and providing informed consent.
排除标准
- •Has prior history of neoadjuvant radiotherapy.
- •Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
- •Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.
- •Has a Body Mass Index (BMI) < 14 or >
- •Is pregnant or is nursing; or plans to become pregnant during the course of the study.
- •Has any connective tissue/autoimmune disorder or rheumatoid disease.
- •Has known allergies to study device materials.
- •Is participating in another interventional research study that may interfere with study endpoints.
- •Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation.
- •Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study.
- •Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.
结局指标
主要结局
Complications of Breast Reconstruction
时间窗: 6 months
Key local complications
次要结局
未报告次要终点
研究者
研究点 (20)
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