Clinical trial NCT03129763: Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling
Official title: Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling for Optimization of Expansion Capsule Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Expander Disorder
Keywords: SPY-ICG Angiography
Tissue Expander
Capsule Pressure
Blood Supply
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Expanded Skin Fluorescence Intensity Decrease Rate in Venous Phase (Unit per-second)
timeFrame: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
Secondary outcomes:
measure: Expanded Skin Fluorescence Intensity Increasion Rate in Arterial Phase (Unit per-second)
timeFrame: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
measure: Expanded Skin Fluorescence Intensity Increasion in Arterial Phase (Unit)
timeFrame: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
measure: Expanded Skin Fluorescence Intensity Decrease in Venous Phase (Unit)
timeFrame: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
name: Qingfeng Li, MD; PhD
role: STUDY_DIRECTOR
References: