The Use of Indocyanine Green Angiography to Predict Expanded Flap Viability

It is a prospective and observational trial that designed to evaluate the effect of intraoperative indocyanine green angiography (ICGA) on prediction of postoperative necrosis and other complications in patients treated with expanded flaps.

Study Overview

Status

Unknown

Conditions

Detailed Description

The lack of suitable soft tissues is a common challenge facing the reconstructive surgeon. Tissue expansion, first described in 1957 by Neumann, is an ingenious technique that can cause body to grow additional skin tissue of similar texture and color to the defect to be repaired and reduce donor site morbidity at the same time. Generally, a silicone balloon expander is inserted under the skin and then gradually filled with saline or carbon dioxide over time, inducing tissue regeneration. Tissue expansion represents one of the major advances in reconstructive surgery and has been widely involved in all kinds of plastic and reconstructive endeavor. In the process of expansion, mechanical stretch also triggers tissue neovascularization and changes in hemodynamic characteristics. These alterations in expanded flap make it challenging to assess flap perfusion and predict postoperative blood flow disorders.

Traditionally, surgeons rely on the clinical experience for determining tissue perfusion, including flap color, capillary refill and pinprick bleeding. However, clinical judgment is highly subjective, difficult to acquire and may be misleading in nonconventional flaps like expanded flaps. Various technologies have been evaluated for perfusion monitoring, including fluorescein angiography, tissue oxygen saturation measurement and thermography. Nevertheless, these are rarely used as routine due to practical limitations, insufficient sensitivity and/or specificity. Recently, Indocyanine Green Angiography (ICGA) has been used for intraoperative evaluation of tissue perfusion. ICGA can give a real-time assessment of flap vascularity and perfusion by intravenously injecting a contrast agent indocyanine green that emits fluorescence when excited by a laser of specific wavelength. Several studies have validated its role in intraoperative evaluation of conventional free and pedicled flap perfusion to aid in surgical decision making and predict postoperative tissue viability. There is obvious difference in hemodynamic characteristics between conventional and expanded flaps so that the conclusion generated from conventional flap study can't be simply extended to expanded flap. In other words, the benefits of ICGA on predicting viability of expanded flaps remains to be validated.

The purpose of this study is to evaluate the effect of intraoperative ICGA on the prediction of flap necrosis in patients underwent tissue expansion. ICGA will be conducted intraoperatively, meanwhile, the possible area of necrosis will be marked according to clinical experience and the fluorescence value of each observation point will be recorded. After 1 week's follow up, the flap viability at each observation point will be assessed by clinical examination. Then, the corresponding fluorescence value will be determined by superimposing digital photography over ICGA imaging results. By analyzing the observation point representing different fate of flap tissue with Logistic regression analysis, ROC curve and area under curve (AUC) can be synthesized by SPSS. A cut-off point can be further identified to achieve both higher positive and negative predictive value, improving the utility and accuracy of ICGA in predicting the postoperative skin viability of expanded flaps.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Shanghai Ninth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who come to the department of plastic and reconstructive surgery in Shanghai ninth people's hospital and undergo tissue expander treatment.

Description

Inclusion Criteria:

  1. Age: 6-50 years old;
  2. Sex: male and female;
  3. Undergo expanded flap treatment;
  4. Possible to suffer from flap necrosis;
  5. Sign the informed consent and are willing to keep following up

Exclusion Criteria:

  1. Present or history of significant medical diseases including infectious, renal, cardiovascular, hepatic, hematological and psychiatric diseases;
  2. 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;
  3. Long history of smoking and/or drinking (>5 years) without quit.
  4. Iodine allergy; Indocyanine green allergy;
  5. Evidence of psychological disorders, no self-awareness and unable to cooperate;
  6. Evidence of malignant diseases or unwillingness to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with expanded flaps
Patients will undergo tissue expansion. When the expanded flaps are harvested and transplanted, ICGA will be conducted intraoperatively. Meanwhile, the possible area of necrosis will be marked according to clinical experience. And then this area will be further divided into perfusion units (1*1 square centimeter for each). The center of each perfusion unit will be marked as observation point, of which the fluorescence value will be recorded. After 1 week's follow-up postoperatively, the flap tissue will be determined by superimposing digital photography over ICGA imaging results, and the outcome of each observation point will be recorded. By analyzing the fluorescence value and outcome of each observation point, a cut-off point can be further identified to achieve both higher positive and negative predictive value, improving the utility and accuracy of ICGA in predicting the postoperative skin viability of expanded flaps.
All patients treated with expanded flaps will be assessed by surgeons, and the possible area of necrosis will be marked based on clinical experience. This area will be further divided into perfusion units (1*1 square centimeter for each), and the center of each perfusion unit will be marked. Then all patients will receive ICGA after the complete transfer of flap to the recipient site. For ICGA, a 2ml bolus of indocyanine green (2.5mg/ml) was injected through the patient's intravenous line. The detector/camera of the SPY imaging system should place over the flap at approximately 30cm for fluorescence image acquisition. The fluorescence value will be recorded afterwards.
Other Names:
  • ICGA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of necrotic and survival observation points and corresponding intraoperative fluorescence values
Time Frame: 7 days post-operation
The clinical outcome of each observation point will be assigned as necrosis or survive 7 days post operation. Necrosis includes epidermolysis, partial/superficial necrosis, and full-thickness necrosis. Partial/superficial necrosis is defined as loss of epidermis and partial loss of dermis with no subcutaneous tissue exposure/no requirement for debridement. Full-thickness necrosis is defined as loss of both epidermis and dermis. The number of necrotic and survival observation points will be recorded respectively, and the intraoperative fluorescence value of each point will be backtracked on SPY-Q afterwards.
7 days post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Tao Zan, MD,PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ICGA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on indocyanine green angiography

3
Subscribe