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

NCT03129763 | Completed

• 1 other identifier: [2017]13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tissue Expander Disorder

Keywords

SPY-ICG Angiography; Tissue Expander; Capsule Pressure; Blood Supply

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• Expanded Skin Fluorescence Intensity Increasion in Arterial Phase (Unit)

  Baseline at visit 1, and post-expanding every two weeks in the follow-up.

• Expanded Skin Fluorescence Intensity Decrease in Venous Phase (Unit)

  Baseline at visit 1, and post-expanding every two weeks in the follow-up.

Study Arms (5)

60mmHg Group

EXPERIMENTAL

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

Behavioral: 60mmHg capsule pressure expansion

70mmHg Group

EXPERIMENTAL

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.

Behavioral: 70mmHg capsule pressure expansion

80mmHg Group

EXPERIMENTAL

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.

Behavioral: 80mmHg capsule pressure expansion

90mmHg Group

EXPERIMENTAL

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.

Behavioral: 90mmHg capsule pressure expansion

100mmHg Group

EXPERIMENTAL

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

Behavioral: 100mmHg capsule pressure expansion

Interventions

60mmHg capsule pressure expansion 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.

60mmHg Group

70mmHg capsule pressure expansion 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.

70mmHg Group

80mmHg capsule pressure expansion 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.

80mmHg Group

90mmHg capsule pressure expansion 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.

90mmHg Group

100mmHg capsule pressure expansion 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.

100mmHg Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

Study Officials

• Qingfeng Li, MD; PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, Head of Departement of Plastic and Reconstructive Surgery, Shanghai 9th People's Hospital

Model Details: This is a prospective randomized controlled trial.

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 26, 2017
• Study Start: January 7, 2017
• Primary Completion: May 5, 2017
• Study Completion: May 25, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

CN (1)