ICGA for Vascular Embolism After Hyaluronic Acid Injection

Value of Indocyanine Green Angiography for Real-Time Assessment of Vascular Embolism Following Hyaluronic Acid Injection

Facial vascular embolism following hyaluronic acid injection is a rare but potentially serious complication that may lead to tissue ischemia, necrosis, and scarring. Early assessment of local tissue perfusion is important for evaluating treatment response and predicting clinical outcomes.

This retrospective observational study aims to evaluate whether indocyanine green angiography (ICGA) can provide objective, real-time information on tissue perfusion in patients with facial vascular embolism after hyaluronic acid injection. The study will review existing medical records, ICGA imaging data, and follow-up information from patients treated at a single center. The main question is whether ICGA findings before and after initial rescue therapy can help assess early perfusion recovery and identify patients who may require additional intervention or develop persistent tissue damage.

Study Overview

• Status: Completed
• Conditions: Embolism Arterial
• Intervention / Treatment: Other: Indocyanine Green Angiography Assessment

Detailed Description

This is a single-center, retrospective, observational study. The study will use existing clinical data generated during prior routine care, including medical records, ICGA imaging data, and follow-up documentation. No additional examinations, treatments, or study-specific follow-up visits will be introduced.

The study focuses on patients with facial vascular embolism following hyaluronic acid injection who underwent ICGA assessment before and immediately after initial rescue therapy. ICGA was performed as part of prior clinical evaluation to visualize local tissue perfusion in real time. Quantitative perfusion-related parameters were obtained using imaging analysis software.

The analysis will compare ICGA-based perfusion changes within the same patient before and after initial rescue therapy. The study will also explore whether baseline perfusion status and early perfusion recovery are associated with subsequent clinical management and tissue outcomes. Patients may be descriptively stratified according to whether additional intervention was required after initial rescue therapy.

All data will be collected retrospectively and de-identified before analysis. The study does not alter previous clinical decision-making and does not expose participants to additional physiological risk. The main study-related risk is potential loss of confidentiality, which will be minimized through de-identification, restricted access to study data, and secure data storage.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100144
      • Plastic Surgery Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of consecutive patients treated at the Center for Wound Repair and Tissue Regeneration, Plastic Surgery Hospital, Chinese Academy of Medical Sciences, for facial vascular embolism following hyaluronic acid injection between July 2025 and March 2026. Participants will be identified retrospectively from existing medical records, indocyanine green angiography imaging data, treatment records, and follow-up documentation generated during routine clinical care.

Description

Inclusion Criteria:

• History of facial hyaluronic acid injection.
• Clinical diagnosis of facial vascular embolism after hyaluronic acid injection, with symptoms or signs such as pain, skin color change, livedo-like discoloration, delayed capillary refill, or tissue ischemia.
• Received initial rescue treatment at the study center.
• Had indocyanine green angiography imaging performed before and immediately after initial rescue treatment as part of routine clinical care.
• Had sufficient medical records and follow-up information available to assess subsequent treatment and tissue outcomes.

Exclusion Criteria:

• Incomplete indocyanine green angiography imaging data.
• Insufficient medical records or follow-up information to assess the main study outcomes.
• Missing key clinical information needed for study analysis.
• Duplicate records or records with concerns about data reliability.
• The patient or legal representative explicitly objected to the use of historical clinical data for this study, if applicable under local ethics requirements.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Within-Participant Change in ICGA-Derived Ingress Rate From Before to After Initial Rescue Therapy	Ingress rate is an indocyanine green angiography-derived perfusion parameter representing the maximum slope of fluorescence intensity increase. It will be measured immediately before initial rescue therapy and immediately after completion of initial rescue therapy. The reported value will be the within-participant change in ingress rate, calculated as the post-treatment value minus the pre-treatment value.	Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
Median Within-Participant Change in ICGA-Derived Time to Peak From Before to After Initial Rescue Therapy	Time to peak is an indocyanine green angiography-derived perfusion parameter representing the time interval from first visible fluorescence to peak fluorescence intensity. It will be measured immediately before initial rescue therapy and immediately after completion of initial rescue therapy. The reported value will be the within-participant change in time to peak, calculated as the post-treatment value minus the pre-treatment value.	Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
Median Within-Participant Change in ICGA-Derived Curve Ingress From Before to After Initial Rescue Therapy	Curve ingress is an indocyanine green angiography-derived perfusion parameter representing the area under the fluorescence-time curve from the start of fluorescence increase to peak fluorescence intensity. It will be measured immediately before initial rescue therapy and immediately after completion of initial rescue therapy. The reported value will be the within-participant change in curve ingress, calculated as the post-treatment value minus the pre-treatment value.	Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy

Collaborators and Investigators

• Sponsor: Chongli Yu
• Collaborators: The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hyaluronidase; Indocyanine green angiography; Rescue therapy; Hyaluronic acid injection; Facial vascular embolism
• Other Study ID Numbers: 2026042018584440

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