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Набор скоро начнётся NCT07345026

Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients

Без фазы С лечением Breast Neoplasms Mastectomy, Segmental

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Acellular Dermal Matrix (SureDerm BCS), Standard Breast-Conserving Surgery.
Кому может быть актуально
Состояния в реестре: Breast Neoplasms, Mastectomy, Segmental. Базовые параметры: 20 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
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Официальное название

Clinical Efficacy of Acellular Dermal Matrix (Product Name: SureDerm BCS) in Breast Cancer Patients Undergoing Breast-Conserving Surgery

Обзор

The goal of this clinical trial is to evaluate whether the use of an acellular dermal matrix (SureDerm) can improve cosmetic satisfaction and is safe in women with breast cancer undergoing breast-conserving surgery. The main questions it aims to answer are: 1. Does the use of SureDerm improve patient-reported cosmetic satisfaction after breast-conserving surgery? 2. Is the use of SureDerm safe in terms of complication rates compared to standard surgery without SureDerm? Researchers will compare patients receiving SureDerm during surgery with patients undergoing standard breast-conserving surgery without SureDerm to see if cosmetic results and safety differ between the groups. Participants will: * Undergo breast-conserving surgery, with or without SureDerm (assigned randomly) * Receive standard postoperative radiotherapy * Complete questionnaires about cosmetic satisfaction (Breast-Q) at baseline, 1 month, and 12 months after surgery * Be followed for complications and cosmetic assessments by physicians

Вмешательства

  • Устройство Acellular Dermal Matrix (SureDerm BCS)
    Participants in this arm will undergo breast-conserving surgery with placement of an acellular dermal matrix (SureDerm BCS). The device is implanted during surgery to provide soft tissue support and improve cosmetic outcomes. All participants will also receive standard postoperative radiotherapy.
  • Процедура Standard Breast-Conserving Surgery
    Participants in this arm will undergo standard breast-conserving surgery without the use of acellular dermal matrix. This procedure involves removal of the breast tumor with preservation of most of the breast tissue. All participants will also receive standard postoperative radiotherapy.

Первичные конечные точки

  • Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q [Срок оценки: Baseline, 1 month after surgery, and 12 months after surgery]
Вторичные конечные точки (3)
  • Incidence of Postoperative Surgical Complications after breast-conserving surgery with or without SureDerm [Срок оценки: 1 month after surgery, and 12 months after surgery]
  • Incidence of Acellular Dermal Matrix (SureDerm)-Related Adverse Events and Local Tissue reaction [Срок оценки: 1 month and 12 months after surgery]
  • Physician-Assessed Cosmetic Outcome Using the Harvard 4-point Cosmetic Scale [Срок оценки: 1 month and 12 months after surgery]

Критерии участия

Критерии включения

  • Female patients aged 20 to 75 years
  • Diagnosed with unilateral breast cancer (ICD-10 code: C50, D05) and treated with breast-conserving surgery
  • Agreed to the use of acellular dermal matrix (ADM) during surgery
  • Histologically confirmed primary breast cancer
  • Patients who received neoadjuvant chemotherapy are eligible
  • Planned to receive standard postoperative treatment, including adjuvant radiotherapy
  • Voluntarily decided to participate in the study and provided written informed consent

Критерии исключения

  • Evidence of distant metastasis
  • Presence of infectious disease, autoimmune disease (e.g., specific rheumatologic disorders), or bleeding/coagulation disorders
  • Known adverse reactions to all first-line antibiotics
  • Suspected inflammatory infection of the breast prior to surgery
  • Pregnant women at the time of enrollment
  • Definite contraindications to the use of acellular dermal matrix
  • Contraindications to radiotherapy
  • Male patients
  • History of another malignancy diagnosed within the past 5 years
  • Patients deemed unsuitable for participation due to difficulty in data collection as judged by the investigator
  • Patients unable to understand or complete the study questionnaires

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea — Seoul

Публикации

  • Kwon J, Byon JH, Ko BK, Kim JS, Bang M. Clinical progression following acellular dermal matrix use for volume replacement after breast-conserving surgery. BMC Surg. 2025 Mar 5;25(1):91. doi: 10.1186/s12893-025-02821-z. PMID 40045324
  • Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807. PMID 19644246

Идентификаторы

NCT: NCT07345026 · XC25EIDV0042

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗