Fluorescence, Surgery
Conditions
Keywords
Reconstructive surgery, Free flap, Pedicled flap, Debridement, Fluorescence imaging, Indocyanine green
Brief 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.
Interventions
DRUGIndocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Sponsors
Amsterdam UMC, location VUmc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum perfusion intensity (Normal) | Once during the surgery | 1\. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame |
| Maximum perfusion intensity (ROI) | Once during the surgery | 2\. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame |
| Relative Perfusion | Once during the surgery | Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame / Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lap Failure | Follow up at six weeks postoperative | Quantified as I \<5%; II 5-15%, III 15-50%, IV\> 50%, V complete |
| Wound infection | Follow up at six weeks postoperative | Defined as none, local wound treatment, antibiotics, or hospitalization. |
| Tmax | Once during the surgery | Time to reach maximum perfusion in region of interest (Tmax, sec) |
| Delayed union | Follow up at six and twelve months postoperative | Radiologic examination (Xray or CT) concluding on the presence of delayed union after 6 months or non-union after 12 months |
| Relative Perfusion before and after tissue transfer | Twice during the surgery | 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 |
| Skin necrosis | Follow up at six weeks postoperative | Defined as none, partial thickness, and full thickness. |
| Ingress | Once during the surgery | Rate of increase in intensity from baseline to peak intensity (Ingress, units) |
| Egress | Once during the surgery | Degree of decrease in intensity from peak to last measurement (Egress, units) |
Countries
Netherlands
Outcome results
None listed