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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60mmHg Group | Experimental | 60mmHg capsule pressure expansion. This pressure depends on the ideal capsule pressure that previous study given. |
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| 70mmHg Group | Experimental | 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. |
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| 80mmHg Group | Experimental | 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. |
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| 90mmHg Group | Experimental | 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. |
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| 100mmHg Group | Experimental | 100mmHg capsule pressure expansion. This pressure gradient depends on the regular expansion pressure in recent studies. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 60mmHg capsule pressure expansion | Behavioral | With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 60mmHg. |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Skin Fluorescence Intensity Decrease Rate in Venous Phase (Unit per-second) | 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. | Baseline at visit 1, and post-expanding every two weeks in the follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Skin Fluorescence Intensity Increasion Rate in Arterial Phase (Unit per-second) | Ingress 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 arteries. | Baseline at visit 1, and post-expanding every two weeks in the follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingfeng Li, MD; PhD | Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200011 | China |
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This is a prospective randomized controlled trial.
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| 70mmHg capsule pressure expansion | Behavioral | With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 70mmHg. |
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| 80mmHg capsule pressure expansion | Behavioral | With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 80mmHg. |
|
| 90mmHg capsule pressure expansion | Behavioral | With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 90mmHg. |
|
| 100mmHg capsule pressure expansion | Behavioral | With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 100mmHg. |
|
| Expanded Skin Fluorescence Intensity Increasion in Arterial Phase (Unit) | Ingress 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 absolute value of expanded skin fluorescence intensity increasion in arterial phase. | Baseline at visit 1, and post-expanding every two weeks in the follow-up. |
| Expanded Skin Fluorescence Intensity Decrease in Venous Phase (Unit) | Engress 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 absolute value of expanded skin fluorescence intensity decrease in venous phase. | Baseline at visit 1, and post-expanding every two weeks in the follow-up. |