Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction

Обзор

The study investigates the safety and performance of Silimed® brand acellular matriz in women born female with indication for breast reconstruction. The safety of the acellular matriz will be evaluated by estimating known and unexpected adverse event rates assessed by clinical evaluations and patient reports of adverse events after implantation in addition to monitoring integration by Magnetic Resonance Imaging (MRI). The performance of Silimed® brand acellular matriz will be evaluated by clinical effectiveness of the acellular matrix in supporting breast reconstruction, reflected by the structural and functional maintenance of the reconstructed tissue without the occurrence of major complications related to integration failure during the follow-up period. Secondary performance outcomes include: assessment of body image-related quality of life, self-esteem assessment, aesthetic and functional breast assessment, and participant satisfaction level.

Вмешательства

• Устройство Acellular matrix
  Silimed® brand acellular matrix

Первичные конечные точки

• Adverse events of the combination of acellular matrix + Silimed® brand breast implants. [Срок оценки: From enrollment to the end of study at 18 months]
• Performance of the combination of acellular matrix + Silimed® brand breast implants. [Срок оценки: From surgery to the end of study at 18 months]

Вторичные конечные точки (4)

• Evaluator's Satisfaction [Срок оценки: From surgery to the end of study at 18 months]
• Participant's Satisfaction [Срок оценки: From surgery to the end of study at 18 months]
• Patient's Quality of Life [Срок оценки: From enrollment to the end of study at 18 months]
• Assessment of body image [Срок оценки: From enrollment to the end of study at 18 months]

Критерии участия

Критерии включения

• Provide written informed consent;
• Female sex at birth;
• Be 18 years of age or older;
• Have an indication for reconstructive surgeries requiring reinforcement, repair, regeneration, and reconstruction of tissues in the breast region;
• Have well-vascularized tissue, according to the physician's clinical assessment, for better cell infiltration, revascularization, and incorporation;
• Have an indication for breast reconstruction with Silimed acellular matrix intended for subcutaneous or submuscular implantation;
• Have an indication for breast reconstruction with Silimed breast implants;
• Have the ability to comply with the protocol for the entire follow-up period.

Критерии исключения

• Breast augmentation without reconstruction in at least one breast;
• Neoplasia of any type that is not yet treated, or is under treatment, or requires surgical removal at the time of implantation\*;
• Pregnancy or breastfeeding at the time of implantation;
• Smoking, uncontrolled diabetes, obesity (grade 2 or higher) or ASA (American Society of Anesthesiology) pre-surgical classification III/IV (ANNEX I);
• Active infection that is not yet treated or is under treatment at any site at the time of implantation;
• Active inflammation that is not yet treated or is under treatment at the implantation site;
• Report or record of adverse reactions or intolerance or known history of hypersensitivity to collagen or bovine products at the time of implantation;
• Report or record of adverse reactions or intolerance to silicone;
• Any immune disorder or disease at the time of implantation;
• Depressed immune system at the time of implantation;
• Report or record of atopy at the time of implantation;
• Record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (e.g., medications that interfere with coagulation);
• High surgical risk or risk of complications in the immediate post-surgical period estimated before implantation;
• Evidence or report of tissue characteristics that are clinically incompatible with successful implantation (e.g., tissues with excessive fibrosis or compromised vascularization);
• Having participated in another clinical study up to 6 months before matrix placement, unless the investigator judges it to be beneficial for the participant and not impacting the study;
• Any other condition that, based on the opinion of the investigator or designated individual, may prevent the provision of informed consent, make participation in the study unsafe, compromise adherence to the protocol, complicate the interpretation of outcome data, or otherwise interfere with the achievement of the study objectives.

• Breast neoplasia where part of the treatment involves an initial surgical approach does not constitute an exclusion criterion, provided that this treatment decision is reported and that the patient is followed by an oncologist.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital de câncer HCIII (INCA) — Rio de Janeiro

Идентификаторы

NCT: NCT07480421 · 5100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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