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

NCT07782801 | Active Not Recruiting DMC

• 2 other identifiers: KazBreastRecAXMBR24992950
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Decellularized xenomatrix; Breast reconstruction; Breast cancer; ADM; AXM

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative complications

  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

Secondary Outcomes (2)

• Pain intensity measured by the Visual Analogue Scale (VAS)

  Postoperative day 3, day 7 and day 14

• Health-related quality of life measured by the 36-Item Short Form Health Survey (SF-36)

  1, 3, 6, 12 and 24 months after surgery

Study Arms (2)

Postmastectomy immediate breast reconstruction using domestic AXM

EXPERIMENTAL

Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using domestic AXM.

Procedure: Radical mastectomy with axillary lymph node dissection; Procedure: Immediate implant-based breast reconstruction; Device: Acellular xenogeneic matrix (AXM)

Postmastectomy immediate breast reconstruction using synthetic mesh prostheses.

ACTIVE COMPARATOR

Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using synthetic mesh prostheses.

Procedure: Radical mastectomy with axillary lymph node dissection; Procedure: Immediate implant-based breast reconstruction; Device: Synthetic mesh prosthesis

Interventions

Radical mastectomy with axillary lymph node dissection PROCEDURE

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

Also known as: Study group (AXM)

Postmastectomy immediate breast reconstruction using domestic AXM; Postmastectomy immediate breast reconstruction using synthetic mesh prostheses.

Immediate implant-based breast reconstruction PROCEDURE

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

Also known as: Control group (synthetic mesh protstheses)

Postmastectomy immediate breast reconstruction using domestic AXM; Postmastectomy immediate breast reconstruction using synthetic mesh prostheses.

Acellular xenogeneic matrix (AXM) DEVICE

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

Postmastectomy immediate breast reconstruction using domestic AXM

Synthetic mesh prosthesis DEVICE

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

Postmastectomy immediate breast reconstruction using synthetic mesh prostheses.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Biological females with XX chromosome
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Oncology and Transplantology Center, Kazakhstan: lead

Study Sites (1)

National Research Oncology Centre

Astana, 010000, Kazakhstan

Location

Related Publications (2)

• Choi YS, You HJ, Lee TY, Kim DW. Comparing Complications of Biologic and Synthetic Mesh in Breast Reconstruction: A Systematic Review and Network Meta-Analysis. Arch Plast Surg. 2023 Feb 6;50(1):3-9. doi: 10.1055/a-1964-8181. eCollection 2023 Jan.

  PMID: 36755646 RESULT

• Colwell AS. One- and two-stage prosthetic reconstruction in nipple-sparing mastectomy. In: Plastic Surgery. 4th ed. Vol. 5. Elsevier; 2018:233-246.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Radical; Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Baurzhan Anapiya

  Baurzhan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Head of skin cance, soft tissues neoplasia and reconstructive surgery department

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)