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

NCT ID: NCT03129763

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-07
• Study Completion Date: 2017-05-25

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.

Conditions

Tissue Expander Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

60mmHg Group

60mmHg capsule pressure expansion. This pressure depends on the ideal capsule pressure that previous study given.

Group Type: EXPERIMENTAL

60mmHg capsule pressure expansion

Intervention Type: 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.

70mmHg Group

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.

Group Type: EXPERIMENTAL

70mmHg capsule pressure expansion

Intervention Type: 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.

80mmHg Group

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.

Group Type: EXPERIMENTAL

80mmHg capsule pressure expansion

Intervention Type: 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 Group

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.

Group Type: EXPERIMENTAL

90mmHg capsule pressure expansion

Intervention Type: 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 Group

100mmHg capsule pressure expansion. This pressure gradient depends on the regular expansion pressure in recent studies.

Group Type: EXPERIMENTAL

100mmHg capsule pressure expansion

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Qing-FengLi Li,MD

MD, PhD, Professor, Head of Departement of Plastic and Reconstructive Surgery, Shanghai 9th People's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingfeng Li, MD; PhD

Role: STUDY_DIRECTOR

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Locations

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

[2017]13

Identifier Type: -

Identifier Source: org_study_id