Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Types and incidence of complications
研究概览
简要总结
Use of a HADM and implant in post-mastectomy breast reconstruction.
详细描述
This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.
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
- •Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction
- •Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
- •Skin incision may be skin sparing, or nipple-areolar sparing
- •Have signed written, informed consent
- •Be at least 18 years of age
排除标准
- •Patients undergoing autologous breast reconstruction
- •Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
- •Patients undergoing reconstruction after previously failed attempts at reconstruction
- •Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
- •There will be no exclusions based on race or ethnicity
- •BMI > 40
- •Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.
研究组 & 干预措施
Flex HD Pliable Perforated HADM
Single Arm
干预措施: Flex HD Pliable Perforated HADM (Other)
结局指标
主要结局
Types and incidence of complications
时间窗: 6 months post reconstruction
Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure
次要结局
- Aesthetic Outcomes(6 months post reconstruction)
- Patient-Reported Outcomes(6 months post reconstruction)