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The Use of Indocyanine Green Angiography to Predict Expanded Flap Viability

NCT04097665 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-12-02

No results posted yet for this study

Summary

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.

Conditions

  • Necorsis

Interventions

DEVICE

indocyanine green angiography

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.

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
5 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04097665 on ClinicalTrials.gov