Tissue Expander Disorder
Conditions
Keywords
SPY-ICG Angiography, Tissue Expander, Capsule Pressure, Blood Supply
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORAL100mmHg capsule pressure expansion
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.
BEHAVIORAL60mmHg capsule pressure expansion
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.
BEHAVIORAL70mmHg capsule pressure expansion
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.
BEHAVIORAL80mmHg capsule pressure expansion
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.
BEHAVIORAL90mmHg capsule pressure expansion
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.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a prospective randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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;
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expanded Skin Fluorescence Intensity Decrease Rate in Venous Phase (Unit per-second) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Expanded Skin Fluorescence Intensity Increasion in Arterial Phase (Unit) | Baseline at visit 1, and post-expanding every two weeks in the follow-up. | 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. |
| Expanded Skin Fluorescence Intensity Decrease in Venous Phase (Unit) | Baseline at visit 1, and post-expanding every two weeks in the follow-up. | 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. |
Countries
China
Outcome results
None listed