ICGA for Vascular Embolism After Hyaluronic Acid Injection

NCT07581652 | Completed

• 1 other identifier: 2026042018584440
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Embolism Arterial

Keywords

Indocyanine green angiography; Hyaluronic acid injection; Facial vascular embolism; Hyaluronidase; Rescue therapy

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Indocyanine Green Angiography Assessment OTHER

Indocyanine green angiography was performed as part of prior routine clinical evaluation to assess local tissue perfusion in patients with facial vascular embolism following hyaluronic acid injection. In this retrospective observational study, existing ICGA imaging data obtained before and immediately after initial rescue therapy will be reviewed and analyzed. No additional ICGA examination will be performed for research purposes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Plastic Surgery Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100144, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: July 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2025-07

Locations

CN (1)