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

Summary

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.

Conditions

• Brest Cancer

Interventions

PROCEDURE

Radical mastectomy with axillary lymph node dissection

Radical mastectomy with axillary lymph node dissection performed as the oncological component of treatment, immediately followed by breast reconstruction in the same operative session.

PROCEDURE

Immediate implant-based breast reconstruction

Immediate breast reconstruction with a permanent implant, performed in the same operative session as mastectomy.

DEVICE

Acellular xenogeneic matrix (AXM)

Domestically produced acellular xenogeneic matrix used for implant coverage and soft tissue support during immediate breast reconstruction.

DEVICE

Synthetic mesh prosthesis

Synthetic mesh prosthesis used for implant coverage and soft tissue support during immediate breast reconstruction.

Sponsors & Collaborators

• National Research Oncology and Transplantology Center, Kazakhstan

  lead OTHER

Principal Investigators

• Baurzhan Anapiya · Baurzhan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-15

Primary Completion

2026-12-30

Completion

2027-01-01

Countries

• Kazakhstan

Study Locations