A Single Arm, Single Center Pilot Study Evaluating the Safety and Healing Time of a Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Graft
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Grafts With Complete Healing
研究概览
简要总结
The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following NAC reconstruction surgery with the BioAesthetics' dcl-hNAC graft.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient age 18-65
- •Patient desires NAC grafting ≥3 months after autologous breast reconstruction
- •Patient agrees to sleep on back until grafts healed (6 weeks)
- •Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until grafts healed (6 weeks)
- •Patient agrees to not undergo NAC tattooing until completing study (12 months)
- •Patient is able to understand and willing to sign informed consent.
排除标准
- •History of delayed wound healing
- •history of Vitamin C deficiency
- •history of diabetes (Type I or Type II)
- •current BMI<18.5 or >40 kg/m,
- •patient has any other uncontrolled comorbidity.
- •Patient has a history of allergic reaction to any decellularized biologic matrix product.
- •Patient is currently smoking or using tobacco or nicotine products (i.e. patch, gum, or nasal spray) or has used such products in the past 12 months.
- •Patient is currently receiving radiation or chemotherapy or received radiation to the breast wall.
- •Patient has a history of prior NAC reconstruction
- •Patient has had NAC tattooing.
- •Patient is pregnant, breastfeeding or planning to become pregnant during the study period.
研究组 & 干预措施
NACgraft patients
uni- or bilateral engraftment surgery will be performed
干预措施: NACgraft (Device)
结局指标
主要结局
Number of Grafts With Complete Healing
时间窗: 3, 6 and 12 months
Complete is defined as when the graft is \>99% epithelialized. Degree of healing will be based on visual assessment by the surgeon and central reviewer with the following metrics on a visual analog scale (VAS): epithelialization (0-100%); granulation (0-100%); overall healing (0-100%). Photographs will be taken using a standardized 3d imaging device, stored and transmitted securely to a central reviewer for independent review.
次要结局
未报告次要终点
研究者
Arash Momeni
Assistant Professor of Surgery
Stanford University