ICG Indocyanine Green in Reconstructive Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Determining Critical Thresholds of Tissue Perfusion With ICG in Reconstructive Surgery

Conditions
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Surgery, Fluorescence

Intervention / Treatment
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* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Debridement after radiotherapy<br>Debridement after radiotherapy | Drug: Indocyanine green<br>* Administration of ICG during surgery and recording of the fluorescence video to perform data analyses<br>|
| Debridement after trauma<br>Debridement after trauma | Drug: Indocyanine green<br>* Administration of ICG during surgery and recording of the fluorescence video to perform data analyses<br>|
| Reconstructive surgery using a fasciocutaneous flap<br>Reconstructive surgery using a fasciocutaneous flap | Drug: Indocyanine green<br>* Administration of ICG during surgery and recording of the fluorescence video to perform data analyses<br>|
| Reconstructive surgery using a muscle flap<br>Reconstructive surgery using a muscle flap | Drug: Indocyanine green<br>* Administration of ICG during surgery and recording of the fluorescence video to perform data analyses<br>|
| Reconstructive surgery using a osseous flap<br>Reconstructive surgery using a osseous flap | Drug: Indocyanine green<br>* Administration of ICG during surgery and recording of the fluorescence video to perform data analyses<br>|
| Vaginaplasties<br>Vaginaplasties using a peritoneum flap or colon interposition | Drug: Indocyanine green<br>* Administration of ICG during surgery and recording of the fluorescence video to perform data analyses<br>|
| Phalloplasties<br>Phalloplasties | Drug: Indocyanine green<br>* Administration of ICG during surgery and recording of the fluorescence video to perform data analyses<br>|
| Finger replantation<br>Finger replantation | Drug: Indocyanine green<br>* Administration of ICG during surgery and recording of the fluorescence video to perform data analyses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum perfusion intensity (Normal) | 1. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame | Once during the surgery | 
| Maximum perfusion intensity (ROI) | 2. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame | Once during the surgery | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Time to reach maximum perfusion in region of interest (Tmax, sec) | Once during the surgery | 
| Ingress | Rate of increase in intensity from baseline to peak intensity (Ingress, units) | Once during the surgery | 
| Egress | Degree of decrease in intensity from peak to last measurement (Egress, units) | Once during the surgery | 
| Lap Failure | Quantified as I <5%; II 5-15%, III 15-50%, IV> 50%, V complete | Follow up at six weeks postoperative | 
| Wound infection | Defined as none, local wound treatment, antibiotics, or hospitalization. | Follow up at six weeks postoperative | 
| Skin necrosis | Defined as none, partial thickness, and full thickness. | Follow up at six weeks postoperative | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reconstructive surgery, Free flap, Pedicled flap, Debridement, Fluorescence imaging, Indocyanine green