Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of protrusions throughout the year
研究概览
简要总结
This study aims to evaluate the efficacy of using a polyester mesh endoprosthesis with a fluoropolymer coating in reducing postoperative complications, particularly protrusions, following subcutaneous mastectomy with simultaneous prepectoral placement of textured breast implants in women with breast cancer
详细描述
The study includes female patients aged 18 and above with a verified breast cancer diagnosis, ECOG performance status 0-1, and clinical stage T1-T3, N0-3, M0, who provide informed consent. Exclusion criteria involve intolerance or allergic reactions to mesh endoprostheses or implants and a subcutaneous adipose tissue thickness of less than 5 mm (measured via Pinch Test). Participants will be non-randomly allocated into two groups: the main group, receiving a polyester mesh endoprosthesis with fluoropolymer coating alongside textured implants, and the control group, receiving textured implants alone. Surgical procedures will involve subcutaneous mastectomy with implant placement based on preoperative measurements of breast dimensions, with or without nipple-areolar complex preservation. Postoperative follow-ups at 1, 3-6, and 9-12 months will assess complications such as protrusions, seromas, implant contouring (rippling), capsular contracture, and dystopia via physical examination and ultrasound. The hypothesis posits that the use of mesh endoprostheses will lower protrusion rates compared to standard implant placement, offering a potential advancement in reducing postoperative risks in breast reconstruction for breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a verified breast cancer diagnosis over 18 years of age;
- •Stage: clinical T1, T2 or T3, N0-3, M0;
- •The thickness of subcutaneous adipose tissue (Pinch Test) is more than 5 mm
- •Signed informed voluntary consent.
排除标准
- •Women under 18 years of age;
- •Stage: clinical T4, M1;
- •The thickness of subcutaneous adipose tissue (Pinch Test) is less than 5 mm;
- •Intolerance and / or allergic reaction to the mesh endoprosthesis, implant and/or its component;
研究组 & 干预措施
Main group
The main group will consist of patients with the planned volume of surgical intervention: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and simultaneous prepectoral placement of textured implants.
干预措施: Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants. (Procedure)
Control group
The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants with no polyester mesh endoprosthesis with a fluoropolymer coating
干预措施: Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants. (Procedure)
结局指标
主要结局
Frequency of protrusions throughout the year
时间窗: 1 year
Implant protrusion is a complication that occurs after reconstructive plastic surgery. In this type of surgery, the implant is displaced from its anatomically correct position leading to its protrusion through the skin. This happens when the integrity or strength of the tissues that hold the implant (such as capsules, muscles, and fascia) is compromised.
次要结局
- 1. Frequency of seroma 2. Frequency of Rippling 3. Frequency of Capsular contracture 4. Frequency of Dystopia(1 year)
研究者
Laisan Shaikhelislamova
Principal Investigator
Saint Petersburg State University, Russia