NCT06129669

ICG Indocyanine Green in Reconstructive Surgery

Determining Critical Thresholds of Tissue Perfusion With ICG in Reconstructive Surgery

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Accepted

Summary

The success or failure of a reconstruction is largely related to the vascularization of the operated area. Near infrared fluorescence (also near infrared fluorescence angiography, NIR FA) with ICG administration is an innovative technique to quantify tissue perfusion. Based on the results obtained in other subspecialties, NIR fluorescence appears to be a promising way to quantify tissue perfusion in reconstructive surgery. Fluorescence research has previously been used in the context of microsurgery and breast reconstructions using implants, but structural objective determinations are lacking. Our study is successful if we are able to determine a cut off value for the absolute or relative perfusion parameters.

Conditions

• Surgery
• Fluorescence

Interventions

Type	Name	Description
DRUG	Indocyanine green	Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Timeline

• Start date: 2023-05-09
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2023-11-13
• Last updated: 2023-11-13

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study