Идёт набор NCT06555614

Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction

— Наблюдательное Breast Cancer Female Breast Reconstruction

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(ADM).
Кому может быть актуально: Состояния в реестре: Breast Cancer Female, Breast Reconstruction. Базовые параметры: 19 лет — 79 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants

Обзор

The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.

Подробное описание

Outline:

The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group.

The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery.

The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024.

After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks.

Primary Objectives

I. To assess whether the test group with applying the ADM processed by the supercritical fluid technology will have less short-term major complications than the control group with the ADM processed by detergents.

Вмешательства

Другое Acellular Dermal Matrix(ADM)
A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.

Первичные конечные точки

Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM [Срок оценки: From the day of operation of breast reconstruction to 12weeks]

Критерии участия

Критерии включения

Prospective Subjects (Test Group):

Female patients aged 19 to 79 years
Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer
Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits

Retrospective Medical Record Collection (Control Group):

Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital
Availability of medical records between March 1, 2021, and March 31, 2024

Критерии исключения

Prospective Subjects (Test Group):

\- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments)

Retrospective Medical Record Collection (Control Group):

\- Patients with no recorded follow-up visits after application of the acellular dermal matrix

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

Здоровые добровольцы: Нет