The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To Measure the Change in Skin Thickness
研究概览
简要总结
The purpose of this study is to evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure.
详细描述
The repair of skin defects is a common problem for reconstructive surgeons.Soft tissue expansion is a widely used technique for the repair of skin defects. Early expansion-related complications such as skin thinning, telangiectasia, and striae may result in expansion failure and ultimately jeopardize final outcome. In the past years, discontinuation of the expansion procedure was the only therapeutic option, when early alarm signs such as semitransparent appearance and telangiectasia of the expanded skin were encountered. We aimed to overcome these complications by therapeutic fat grafting to prevent skin necrosis and enable continuation of the expansion procedure.
Patients undergoing soft tissue expansion treatment for resurfacing skin lesions including scars and nevi that required therapeutic intervention due to early complication signs were included in this study. Patients were randomly divided into treatment group using autologous fat grafting and control group with discontinued expansion and expectant management. The treatment group received autologous fat transfer to the expanded skin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- •Implanted silicone expander of 50 to 800 ml in size;
- •History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- •Persistent high level of expander internal pressure;
- •Need for further skin expansion;
排除标准
- •Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
- •Rupture of expanded skin, expander exposure;
- •Significant renal, cardiovascular, hepatic and psychiatric diseases;
- •Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
- •BMI less than 17 or insufficient subcutaneous fat;
- •History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
- •History of allogenic bone marrow transplantation;
- •Pregnant or lactating woman;
- •Long history of smoking;
- •Evidence of malignant diseases or unwillingness to participate
结局指标
主要结局
To Measure the Change in Skin Thickness
时间窗: Change from baseline skin thickness at 12 weeks
Record the thickness of the expanded skin(cm) by ultrasound scanning
To Measure the Change in Expansion Volume
时间窗: Change from baseline volume at 12 weeks
Record the volume(ml) of each expander
次要结局
- To Measure the Texture of Expanded Flap with VISIA scanner(baseline and 12 weeks post treatment)
- Occurence of Major Adverse Events(Up to approximately 12 weeks after study start)
研究者
Qing-FengLi Li,MD
Director of plastic and reconstructive surgery department
Shanghai Jiao Tong University School of Medicine