A Prospective, Randomized, Multi-Center Clinical Study Comparing Outcomes in Patients Undergoing Prosthetic, Acellular Dermal Matrix (ADM) Assisted, Immediate Post-Mastectomy Breast Reconstruction
试验速览
- 阶段
- 不适用
- 入组人数
- 224
- 试验地点
- 13
- 主要终点
- Post Reconstruction Complication Rates
研究概览
简要总结
Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two allograft dermal matrices (ADMs) currently in use for tissue assisted immediate post-mastectomy breast reconstruction.
详细描述
This is a level one, prospective, randomized, controlled multi-center clinical study comparing two types of acellular dermal matrices (ADMs) currently used in immediate post-mastectomy prosthetic breast reconstruction. Comparison of these two ADMs will be made in the areas of reconstructive clinical outcomes and aesthetic outcomes. Patients will be randomized into one of two ADM groups as part of their immediate post-mastectomy breast reconstruction. Patients in both groups will be followed for twelve months after their reconstructive surgery. Clinical outcomes will be documented at 1 month, 3 months, 6 months and 12 months following breast reconstructive surgery. For one-stage breast reconstruction, aesthetic outcomes will be assessed and documented at 6 and 12 months following implant placement. For two-stage reconstruction, patients will be evaluated for aesthetic outcomes at a time point 6-12 months following expander-to-implant exchange if it does not coincide with the 12 month post-mastectomy visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
3-4 independent breast surgeons using predefined criteria will assess the aesthetic outcomes of each subject using photographs of their pre-mastectomy and 12 month post-reconstructions. The surgeons will not be apprised of the ADM type or post-mastectomy site/surgeon
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
- •Scheduled to undergo immediate, post-mastectomy, tissue assisted breast reconstruction, Reconstruction shall be either one-stage (direct-to-implant) or two-stage, unilateral or bilateral, prophylactic or therapeutic
- •Females at least 18 years of age
- •Non-smokers, former smokers and/or smokers who have not smoked within 1 month before surgery, and who agree to not smoke or utilize e-cigarettes during the post-operative period
- •Have signed a written informed consent
- •Have the ability to understand and comply with the requirements and follow-up time points of the study
排除标准
- •Previous breast surgery with the exception of biopsy
- •Previous radiation treatment in either breast at any time
- •Undergoing autologous breast reconstruction
- •Pre-pectoral implant placement
- •Undergoing delayed reconstruction
- •Requiring Wise pattern reduction of mastectomy skin flap
- •History of chronic steroid use within the past 6 months
- •History of HIV positive
- •Previous organ transplant
- •Pregnant or lactating females
- •Clinically significant systemic disease, as determined by the investigator, which could affect study participation or study results
研究组 & 干预措施
Cohort A
FlexHD ADM
干预措施: FlexHD ADM (Cohort A) (Biological)
Cohort B
AlloDerm RTU ADM
干预措施: AlloDerm RTU ADM (Cohort B) (Biological)
结局指标
主要结局
Post Reconstruction Complication Rates
时间窗: 12 months
To compare the overall complication rate between the cohorts defined as either 1) post-operative infection specific to the reconstructed breast(s) requiring either intravenous antibiotic treatment or operative intervention, 2) seroma, and/or 3) reconstructive failure
次要结局
- Comparison of Each Complication Rate(12 months)
- Comparison of Aesthetic Outcomes (Photographs)(12 months)