ICG Indocyanine Green in Reconstructive Surgery
- Conditions
- SurgeryFluorescence
- Interventions
- Registration Number
- NCT06129669
- Lead Sponsor
- Amsterdam UMC, location VUmc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 160
- Aged 18 or older
- Undergoing debridement and/or reconstructive surgery included in the aforementioned groups
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Debridement after radiotherapy Indocyanine green Debridement after radiotherapy Debridement after trauma Indocyanine green Debridement after trauma Reconstructive surgery using a fasciocutaneous flap Indocyanine green Reconstructive surgery using a fasciocutaneous flap Reconstructive surgery using a muscle flap Indocyanine green Reconstructive surgery using a muscle flap Reconstructive surgery using a osseous flap Indocyanine green Reconstructive surgery using a osseous flap Phalloplasties Indocyanine green Phalloplasties Vaginaplasties Indocyanine green Vaginaplasties using a peritoneum flap or colon interposition Finger replantation Indocyanine green Finger replantation
- Primary Outcome Measures
Name Time Method 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
Maximum perfusion intensity (ROI) Once during the surgery 2. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
Maximum perfusion intensity (Normal) Once during the surgery 1. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
- Secondary Outcome Measures
Name Time Method 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)
Tmax Once during the surgery Time to reach maximum perfusion in region of interest (Tmax, sec)
Wound infection Follow up at six weeks postoperative Defined as none, local wound treatment, antibiotics, or hospitalization.
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
Lap Failure Follow up at six weeks postoperative Quantified as I \<5%; II 5-15%, III 15-50%, IV\> 50%, V complete
Skin necrosis Follow up at six weeks postoperative Defined as none, partial thickness, and full thickness.
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
Trial Locations
- Locations (1)
Amsterdam UMC
🇳🇱Amsterdam, Netherlands