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Creation and Implementation a Method for Breast Reconstruction After Radical Surgery Using Decellularized Xenomatrix in Combination With Lymphovenous Anastomosis in Breast Cancer.

2026年8月26日 更新者:Bauyrzhan Anapiya、National Research Oncology and Transplantology Center, Kazakhstan

In 2020, more than 31,000 new cancer cases were reported in Kazakhstan, with breast cancer being the most common type, accounting for more than 4,200 new cases. This pattern has also been observed in previous years, making breast cancer a major public health concern in the country.

Fortunately, approximately 94% of breast cancer cases are diagnosed at stages I-III, when treatment is generally possible. Nevertheless, treatment, particularly surgery, can be physically and emotionally challenging. Patients may develop postoperative complications such as scar contractures and lymphedema. In addition, breast loss can significantly affect body image, sense of femininity, psychological well-being, and social reintegration.

To improve functional and psychosocial outcomes, immediate breast reconstruction has become an important component of modern breast cancer surgery. Implant-based immediate reconstruction is widely used and can restore breast contour during the same surgical procedure as tumor removal.

However, implant-based reconstruction in breast cancer patients requires reliable fixation and coverage of the implant. Synthetic meshes are commonly used for this purpose, but they may be associated with complications such as inflammation, fibrosis, infection, and implant exposure.

An alternative approach is the use of biological materials derived from animal tissues, particularly acellular collagen matrices. These materials are designed to provide structural support while allowing integration with surrounding tissues. Their clinical performance, however, may vary depending on their biological origin and processing methods, and their high cost can limit their accessibility.

To address these limitations, Kazakhstani researchers developed a domestic acellular xenogeneic matrix (AXM) based on specially processed bovine peritoneum. The material has demonstrated promising results as a wound covering in preclinical and clinical studies, including applications involving implantation within the body.

The current research aims to evaluate whether AXM can be effectively used as a fixation material for breast implants in patients undergoing immediate breast reconstruction after breast cancer surgery. Because implant fixation requires sufficient mechanical strength and stable integration with surrounding tissues, further clinical evaluation is needed to establish the safety, reliability, and cost-effectiveness of AXM as a domestic alternative to commercially available biological matrices.

研究概览

详细说明

According to official statistical data for 2020, 31,505 new cases of cancer were registered in Kazakhstan. Among them, 4,272 were cases of malignant breast neoplasms, making breast cancer the most commonly diagnosed malignancy in the country. This trend has also been observed in previous years, highlighting breast cancer as an important public health concern.

Despite the fact that approximately 94.3% of breast cancer cases are diagnosed at stages I-III, when effective treatment is generally possible, treatment itself remains a significant challenge for patients. Surgical treatment may be associated with delayed complications such as scar contractures and lymphedema. From a psychosocial and quality-of-life perspective, breast loss may significantly affect body image, sense of femininity, psychological well-being, and social reintegration.

In modern breast oncology, immediate breast reconstruction with implants has become an important component of surgical treatment. However, implant-based reconstruction requires reliable fixation and adequate coverage of the implant. Synthetic meshes, including those based on polytetrafluoroethylene and other synthetic polymers, are commonly used for this purpose but may be associated with complications such as reactive inflammation, fibrosis, infection, and implant exposure.

As an alternative to synthetic materials, acellular collagen matrices of animal origin have been introduced into reconstructive breast surgery. These biological materials provide structural support and may facilitate integration with surrounding tissues. However, studies have demonstrated that xenogeneic matrices can differ substantially in their biological behavior depending on their tissue origin and processing methods. In addition, the high cost of commercially available matrices remains a significant limitation to their widespread use.

To address this issue, a group of Kazakhstani researchers developed and patented a domestic wound covering based on acellular bovine peritoneum, known as AXM. The material has demonstrated promising results as a wound covering in preclinical and clinical settings, including applications involving implantation within the body.

However, the use of AXM as a fixation material for breast implants represents a distinct clinical application. Unlike wound coverage, implant fixation requires the matrix to withstand mechanical tension and provide stable long-term support while integrating with the surrounding tissues. Given the differences in the biological and mechanical properties of xenogeneic matrices from different sources, the safety, effectiveness, and reliability of the domestic AXM as a fixation material for breast implants require further clinical evaluation.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Astana、哈萨克斯坦、010000
        • National Research Oncology Centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients with verified stage I-II breast cancer
  • Age 18-65 years
  • Absence of accompanying endocrine, cardiovascular, or neurological pathologies in decompensation stage.
  • Absence of neurological or psychological deviations affecting capacity.
  • Absence of pregnancy
  • Absence of HIV, zoonotic infections.
  • Absence of allergic reactions to materials or components included in ADM.
  • Absence of concomitant oncological diseases, including oncohematological pathology.

Exclusion Criteria:

  • Patients with unverified malignant breast tumors.
  • Patients with stage III-IV malignant breast tumors.
  • Age under 18 years
  • Presence of accompanying endocrine, cardiovascular, or neurological pathologies in decompensation stage.
  • Presence of neurological or psychological deviations affecting capacity.
  • Pregnancy
  • HIV, zoonotic infections.
  • Presence of allergic reactions to materials or components included in ADM.
  • Presence of concomitant oncological diseases, including oncohematological pathology.
  • Intolerance to ADM or its components.
  • Medical indications arising during the study.
  • Patient non-compliance (failure to comply with postoperative regimen).
  • Cessation of therapy for more than 24 hours at the patient's request.
  • Non-compliance with participation rules in the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Postmastectomy immediate breast reconstruction using domestic AXM
Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using domestic AXM.
Radical mastectomy with axillary lymph node dissection performed as the oncological component of treatment, immediately followed by breast reconstruction in the same operative session.
其他名称:
  • Study group (AXM)
Immediate breast reconstruction with a permanent implant, performed in the same operative session as mastectomy.
其他名称:
  • Control group (synthetic mesh protstheses)
Domestically produced acellular xenogeneic matrix used for implant coverage and soft tissue support during immediate breast reconstruction.
有源比较器:Postmastectomy immediate breast reconstruction using synthetic mesh prostheses.
Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using synthetic mesh prostheses.
Radical mastectomy with axillary lymph node dissection performed as the oncological component of treatment, immediately followed by breast reconstruction in the same operative session.
其他名称:
  • Study group (AXM)
Immediate breast reconstruction with a permanent implant, performed in the same operative session as mastectomy.
其他名称:
  • Control group (synthetic mesh protstheses)
Synthetic mesh prosthesis used for implant coverage and soft tissue support during immediate breast reconstruction.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of postoperative complications
大体时间:1, 3, 6, 12 and 24 months after surgery
Proportion of participants with at least one postoperative complication after immediate implant-based breast reconstruction using acellular xenogeneic matrix or synthetic mesh prosthesis. Complications include surgical site infection, seroma, haematoma, skin or nipple-areola necrosis, wound dehiscence, implant exposure, capsular contracture and implant loss, graded according to the Clavien-Dindo classification.
1, 3, 6, 12 and 24 months after surgery

次要结果测量

结果测量
措施说明
大体时间
Pain intensity measured by the Visual Analogue Scale (VAS)
大体时间:Postoperative day 3, day 7 and day 14
Postoperative pain intensity assessed using the Visual Analogue Scale (VAS), an 11-point numeric scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain.
Postoperative day 3, day 7 and day 14
Health-related quality of life measured by the 36-Item Short Form Health Survey (SF-36)
大体时间:1, 3, 6, 12 and 24 months after surgery
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Each of the eight domain scores ranges from 0 to 100, where 0 represents the worst and 100 the best possible health status. Higher scores indicate a better outcome.
1, 3, 6, 12 and 24 months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Baurzhan Anapiya、Baurzhan

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月15日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年8月19日

首先提交符合 QC 标准的

2026年8月19日

首次发布 (实际的)

2026年8月24日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • KazBreastRecAXM
  • BR24992950 (其他赠款/资助编号:Committee of Science of the Ministry of Science and Higher Education of the Republic of Kazakhstan)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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