UnknownNot Applicable

The Use of Indocyanine Green Angiography to Predict Expanded Flap Viability

China30 participantsStarted 2019-11-18

Plain-language 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.

Who can participate

Age range5 Years – 60 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

The number of necrotic and survival observation points and corresponding intraoperative fluorescence values

Timeframe: 7 days post-operation

Trial details

NCT IDNCT04097665

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

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