NCT05182177已完成不适用
A Multi-Center, Retrospective Review of Implant-Based Post Mastectomy Breast Reconstruction Utilizing SurgiMend® Collagen Matrix in Prepectoral and Submuscular Surgical Approaches
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 6
- 主要终点
- Performance of SurgiMend
研究概览
简要总结
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The patient has reviewed the ethics-approved consent form and has provided consent for data collection
- •Subject is a female over the age of 18 at the time of index surgery (mastectomy)
- •Subject had mastectomy performed for cancer or as a cancer prophylaxis
- •The surgical plan included one of the following approaches:
- •Immediate unilateral or bilateral prepectoral DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skinreducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
- •Immediate unilateral or bilateral submuscular DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skin-reducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
- •If subject received bilateral breast reconstruction, the subject must have received the same surgical technique for both breasts including the implantation of SurgiMend® PRS or SurgiMend® PRS Meshed
- •If subject received unilateral breast reconstruction, there was no surgical intervention on the contralateral breast within 12 months post-operatively
- •Subject underwent mastectomy (index surgery) at a minimum of 24 months prior to study initiation at site
排除标准
- •The surgical plan included muscle flaps to supplement the breast mound
- •The reconstruction plan included hybrid implant coverage with another type of mesh (e.g., use of another mesh or ADM in addition to SurgiMend®)
- •Subject had received prior breast augmentation, mastopexy, or breast reduction surgeries (does not include breast biopsy)
- •Subject was a user of any nicotine products (cigarettes, chewing tobacco, vapor, etc.) (within 6 weeks before index surgery)
- •Subject had uncontrolled Type I or Type II diabetes (HbA1C >9)
- •Subject had previously undergone radiation therapy to the chest wall prior to index surgery
- •Subject had been diagnosed with advanced stage disease (stage 3 or 4, or inflammatory cancer)
结局指标
主要结局
Performance of SurgiMend
时间窗: 24 months
The primary endpoint of this study is the proportion of patients who did not require additional surgical interventions at or associated with the site of the original reconstruction within 12 months after SurgiMend® PRS or SurgiMend® PRS Meshed implantation.
次要结局
- Safety of SurgiMend(24 months)
研究者
研究点 (6)
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