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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.

2026년 8월 26일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Astana, 카자흐스탄, 010000
        • National Research Oncology Centre

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른 이름들:
  • Study group (AXM)
Immediate breast reconstruction with a permanent implant, performed in the same operative session as mastectomy.
다른 이름들:
  • Control group (synthetic mesh protstheses)
Domestically produced acellular xenogeneic matrix used for implant coverage and soft tissue support during immediate breast reconstruction.
활성 비교기: 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.
다른 이름들:
  • Study group (AXM)
Immediate breast reconstruction with a permanent implant, performed in the same operative session as mastectomy.
다른 이름들:
  • Control group (synthetic mesh protstheses)
Synthetic mesh prosthesis used for implant coverage and soft tissue support during immediate breast reconstruction.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of postoperative complications
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Pain intensity measured by the Visual Analogue Scale (VAS)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Baurzhan Anapiya, Baurzhan

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 1월 15일

기본 완료 (추정된)

2026년 12월 30일

연구 완료 (추정된)

2027년 1월 1일

연구 등록 날짜

최초 제출

2026년 8월 19일

QC 기준을 충족하는 최초 제출

2026년 8월 19일

처음 게시됨 (실제)

2026년 8월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 26일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • KazBreastRecAXM
  • BR24992950 (기타 보조금/기금 번호: Committee of Science of the Ministry of Science and Higher Education of the Republic of Kazakhstan)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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