ICG Indocyanine Green in Reconstructive Surgery

Surgery Clinical Trial

— ICG-R  

Official title:

Determining Critical Thresholds of Tissue Perfusion With ICG in Reconstructive Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06129669
• Other study ID #: NL74852.029.21
• Status: Enrolling by invitation
• Start date: May 9, 2023
• Est. completion date: May 2025

Study information

• Verified date: November 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• Aged 18 or older

• Undergoing debridement and/or reconstructive surgery included in the aforementioned groups

Exclusion Criteria:

• allergy or hypersensitivity to sodium iodide, iodine, ICG or shellfish

• patients with hyperthyroidism and patients with autonomic thyroid adenoma

• pregnancy or lactation

• epilepsy

• severe liver failure

• renal failure with a GFR <60.

Related Conditions & MeSH terms

• Fluorescence
• Surgery

Intervention

Drug:
• Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum perfusion intensity (Normal)	1. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame	Once during the surgery
Primary	Maximum perfusion intensity (ROI)	2. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame	Once during the surgery
Primary	Relative Perfusion	Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame / Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame	Once during the surgery
Secondary	Tmax	Time to reach maximum perfusion in region of interest (Tmax, sec)	Once during the surgery
Secondary	Ingress	Rate of increase in intensity from baseline to peak intensity (Ingress, units)	Once during the surgery
Secondary	Egress	Degree of decrease in intensity from peak to last measurement (Egress, units)	Once during the surgery
Secondary	Lap Failure	Quantified as I <5%; II 5-15%, III 15-50%, IV> 50%, V complete	Follow up at six weeks postoperative
Secondary	Wound infection	Defined as none, local wound treatment, antibiotics, or hospitalization.	Follow up at six weeks postoperative
Secondary	Skin necrosis	Defined as none, partial thickness, and full thickness.	Follow up at six weeks postoperative
Secondary	Delayed union	Radiologic examination (Xray or CT) concluding on the presence of delayed union after 6 months or non-union after 12 months	Follow up at six and twelve months postoperative
Secondary	Relative Perfusion before and after tissue transfer	Maximum perfusion intensity (Imax, units) in the same reference frame after tissue transfer / Maximum perfusion intensity (Imax, units) in a reference frame before tissue transfer	Twice during the surgery