Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Adverse events of the combination of acellular matrix + Silimed® brand breast implants.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Women undergoing breast reconstruction with Silimed® Acellular Matrix
干预措施: Acellular matrix (Device)
结局指标
主要结局
Adverse events of the combination of acellular matrix + Silimed® brand breast implants.
时间窗: From enrollment to the end of study at 18 months
To estimate the risk and rate of expected and unexpected adverse events from the combination of acellular matrix + Silimed® brand breast implants
Performance of the combination of acellular matrix + Silimed® brand breast implants.
时间窗: From surgery to the end of study at 18 months
Evaluation of the clinical efficacy 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. Acellular Matrix is indicated for the reinforcement, repair, regeneration, and reconstruction of breast tissue in reconstructive surgeries. Its adequate integration into the recipient tissue is an essential parameter of the expected clinical performance, as it enables the incorporation of the material into the surgical bed and the success of the reconstructive process. Matrix integration will be evaluated by magnetic resonance imaging in approximately one-third of the study population. It should be noted that the degree and time of integration may vary between patients, influenced by individual factors such as biological characteristics, inflammatory response, and local.
次要结局
- Evaluator's Satisfaction(From surgery to the end of study at 18 months)
- Participant's Satisfaction(From surgery to the end of study at 18 months)
- Patient's Quality of Life(From enrollment to the end of study at 18 months)
- Assessment of body image(From enrollment to the end of study at 18 months)