Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling for Optimization of Expansion Capsule Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Expanded Skin Fluorescence Intensity Decrease Rate in Venous Phase (Unit per-second)
研究概览
简要总结
The purpose of this study is to optimize the expansion pressure by compare different capsule pressures' effect, the blood supply of expanded skin is assessed by the Indocyanine Green-SPY Angiography.
详细描述
This is a randomized controlled trial that designed to optimize the tissue expander expanding method. All the patients were randomly divided into five groups, patients in different groups received an expansion weekly with different capsule pressure of 60mmHg, 70mmHg, 80mmHg, 90mmHg and 100mmHg respectively. Each patient received an expanding once a week, and a hemodynamic assessment of SPY-ICG angiography every two weeks. The total follow-up for each patient is 8 weeks.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 to 50 years;
- •Expanding skin donor site at the face, neck, anterior chest wall or back;
- •Implanted silicone expander of 100 to 600 ml in size; The quantitiy of normal saline in the tissue expander is more than the original volume, and less than double original volume.
- •Need for further skin expansion; with previous regular expanding in hospital;
排除标准
- •Iodine allergy; Indocyanine green allergy;
- •Not fit for soft tissue expansion treatment;
- •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;
- •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 >30;
- •History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
- •History of allogenic bone marrow transplantation;
- •Long history of smoking;Evidence of malignant diseases or unwillingness to participate.
研究组 & 干预措施
60mmHg Group
60mmHg capsule pressure expansion. This pressure depends on the ideal capsule pressure that previous study given.
干预措施: 60mmHg capsule pressure expansion (Behavioral)
70mmHg Group
70mmHg capsule pressure expansion. This pressure gradient depends on the ideal capsule pressure that previous study given, and the regular expansion pressure in recent studies.
干预措施: 70mmHg capsule pressure expansion (Behavioral)
80mmHg Group
80mmHg capsule pressure expansion. This pressure gradient depends on the ideal capsule pressure that previous study given, and the regular expansion pressure in recent studies.
干预措施: 80mmHg capsule pressure expansion (Behavioral)
90mmHg Group
90mmHg capsule pressure expansion. This pressure gradient depends on the ideal capsule pressure that previous study given, and the regular expansion pressure in recent studies.
干预措施: 90mmHg capsule pressure expansion (Behavioral)
100mmHg Group
100mmHg capsule pressure expansion. This pressure gradient depends on the regular expansion pressure in recent studies.
干预措施: 100mmHg capsule pressure expansion (Behavioral)
结局指标
主要结局
Expanded Skin Fluorescence Intensity Decrease Rate in Venous Phase (Unit per-second)
时间窗: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
Engress Rate is one of the expanded skin perfusion relative quantitative index of Indocyanine Green-SPY Angiography. It is obtained by SPY-Q analysis, which represents the flow of expanded skin veins.
次要结局
- Expanded Skin Fluorescence Intensity Increasion Rate in Arterial Phase (Unit per-second)(Baseline at visit 1, and post-expanding every two weeks in the follow-up.)
- Expanded Skin Fluorescence Intensity Increasion in Arterial Phase (Unit)(Baseline at visit 1, and post-expanding every two weeks in the follow-up.)
- Expanded Skin Fluorescence Intensity Decrease in Venous Phase (Unit)(Baseline at visit 1, and post-expanding every two weeks in the follow-up.)
研究者
Qing-FengLi Li,MD
MD, PhD, Professor, Head of Departement of Plastic and Reconstructive Surgery, Shanghai 9th People's Hospital
Shanghai Jiao Tong University School of Medicine