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

Tissue Expander Disorder Clinical Trial

Official title:

Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling for Optimization of Expansion Capsule Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129763
• Other study ID #: [2017]13
• Status: Completed
• Phase: N/A
• First received: April 14, 2017
• Last updated: May 29, 2017
• Start date: January 7, 2017
• Est. completion date: May 25, 2017

Study information

• Verified date: May 2017
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 25, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tissue Expander Disorder

Intervention

Behavioral:
• 60mmHg 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.
• 70mmHg 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.
• 80mmHg 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.
• 90mmHg 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.
• 100mmHg 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.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.