Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling

Not Applicable

Completed

• Conditions: Tissue Expander Disorder

• Registration Number: NCT03129763
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2017-01-07
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-26
• Status Verified: 2017-05
• Primary Completion: 2017-05-05
• Study Completion: 2017-05-25
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China