Creation and Implementation a Method for Breast Reconstruction After Radical Surgery Using Decellularized Xenomatrix in Combination With Lymphovenous Anastomosis in Breast Cancer.
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Astana, Kazakhstan, 010000
- National Research Oncology Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Postmastectomy immediate breast reconstruction using domestic AXM
Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using domestic AXM.
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Radical mastectomy with axillary lymph node dissection performed as the oncological component of treatment, immediately followed by breast reconstruction in the same operative session.
Other Names:
Immediate breast reconstruction with a permanent implant, performed in the same operative session as mastectomy.
Other Names:
Domestically produced acellular xenogeneic matrix used for implant coverage and soft tissue support during immediate breast reconstruction.
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Active Comparator: 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.
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Radical mastectomy with axillary lymph node dissection performed as the oncological component of treatment, immediately followed by breast reconstruction in the same operative session.
Other Names:
Immediate breast reconstruction with a permanent implant, performed in the same operative session as mastectomy.
Other Names:
Synthetic mesh prosthesis used for implant coverage and soft tissue support during immediate breast reconstruction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of postoperative complications
Time Frame: 1, 3, 6, 12 and 24 months after surgery
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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.
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1, 3, 6, 12 and 24 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity measured by the Visual Analogue Scale (VAS)
Time Frame: Postoperative day 3, day 7 and day 14
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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.
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Postoperative day 3, day 7 and day 14
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Health-related quality of life measured by the 36-Item Short Form Health Survey (SF-36)
Time Frame: 1, 3, 6, 12 and 24 months after surgery
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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.
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1, 3, 6, 12 and 24 months after surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Baurzhan Anapiya, Baurzhan
Publications and helpful links
General Publications
- 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.
- Colwell AS. One- and two-stage prosthetic reconstruction in nipple-sparing mastectomy. In: Plastic Surgery. 4th ed. Vol. 5. Elsevier; 2018:233-246.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KazBreastRecAXM
- BR24992950 (Other Grant/Funding Number: Committee of Science of the Ministry of Science and Higher Education of the Republic of Kazakhstan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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