In-Vivo Assessment of Adipose Allograft Extracellular Matrix in Abdominoplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Histopathology evaluation for number of mature adipocytes via haematoxylin and eosin staining.
研究概览
简要总结
The purpose of this study is to assess local tissue reaction and retention of an adipose allograft extracellular matrix at 3 or 6 months post-injection into the subcutaneous abdominal tissue of healthy volunteers scheduled to undergo elective panniculectomy.
详细描述
This is a prospective, randomized, two arm, single center study to assess adipose tissue development and retention when an implantable allograft adipose matrix ('AAM') is injected in the abdominal subcutaneous tissue of healthy volunteers undergoing elective standard-of-care panniculectomy. This study will enroll ten (10) subjects. These subjects will be randomized to one of two study arms. Arm 1 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for three (3) months duration, and arm 2 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for six (6) months duration. At the point of completion of each arm, 3 or 6 months, the injected tissue will be surgically removed as part of the panniculectomy procedure. Samples of the AAM injected tissue areas and surrounding tissue will be obtained and processed for histologic evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Thickness of subcutaneous tissue on abdominal wall is less than 2cm thick.
- •Previous liposuction at intended sites of treatment.
- •Actively taking immunosuppressive therapy including systemic steroids (intranasal/inhaled steroids are acceptable).
- •Actively receiving chemotherapy or radiation treatment.
- •Subjects with a life expectancy of less than 9 months, terminal conditions or factors making follow-up difficult (e.g.; no fixed address, telephone, etc.)
- •Subjects with intolerance to additional study-associated drugs/therapies (e.g.; lidocaine, etc.).
- •Subjects with known coagulopathy.
- •Subjects on chronic anticoagulants (e.g. Coumadin, etc.).
- •Subjects who are pregnant, lactating or planning pregnancy during the study period.
- •Subjects with abnormal blood chemistry or any abnormal laboratory finding considered clinically significant in that it would deem the subject inappropriate for surgical procedures, as determined by the Investigator (i.e., CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests).
- •Subjects who have, as determined by the investigator, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study (e.g.; Type I and II diabetic patients).
- •Subjects with known alcohol or narcotic drug dependency that is deemed to impact compliance.
- •Subjects with diagnosed autoimmune disorders known to affect wound healing, such as Systemic Lupus Erythematosis (SLE), psoriasis, infection and inflammation (seborrheic dermatitis).
- •Subjects currently enrolled in another investigational study.
- •Study Population Description: Patients scheduled to undergo elective abdominoplasty Sampling Method: Invitation to volunteer
研究组 & 干预措施
3 Mo. Post AAM Injection
Injection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 3 months.
干预措施: Adipose Allograft Extracellular Matrix (AAM) Injection (Procedure)
6 Month Post AAM Injection
Injection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 6 months.
干预措施: Adipose Allograft Extracellular Matrix (AAM) Injection (Procedure)
结局指标
主要结局
Histopathology evaluation for number of mature adipocytes via haematoxylin and eosin staining.
时间窗: 6 months
Change from baseline to 6 months in abdominal tissue samples using H \& E staining
次要结局
- Safety of allograft adipose matrix (AAM) injections as determined by the incidence of adverse events.(6 months)