Clinical trial · Interventional
Creation and Implementation a Method for Breast Reconstruction After Radical Surgery Using Decellularized Xenomatrix in Combination With Lymphovenous Anastomosis in Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brest Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acellular xenogeneic matrix (AXM) | Device | — | UNRESOLVED |
| Immediate implant-based breast reconstruction | Procedure | — | UNRESOLVED |
| Radical mastectomy with axillary lymph node dissection | Procedure | — | UNRESOLVED |
| Synthetic mesh prosthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Postmastectomy immediate breast reconstruction using domestic AXM
- description
- Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using domestic AXM.
- interventionNames
- Procedure: Radical mastectomy with axillary lymph node dissection
- Procedure: Immediate implant-based breast reconstruction
- Device: Acellular xenogeneic matrix (AXM)
- type
- ACTIVE_COMPARATOR
- label
- Postmastectomy immediate breast reconstruction using synthetic mesh prostheses.
- description
- Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using synthetic mesh prostheses.
- interventionNames
- Procedure: Radical mastectomy with axillary lymph node dissection
- Procedure: Immediate implant-based breast reconstruction
- Device: Synthetic mesh prosthesis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTChoi 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
- RESULTColwell AS. One- and two-stage prosthetic reconstruction in nipple-sparing mastectomy. In: Plastic Surgery. 4th ed. Vol. 5. Elsevier; 2018:233-246.