Defects caused by oncological resection or trauma.
Conditions
Interventions
There will be no interventions in this study, it is an observational study
Sponsors
none
Eligibility
Inclusion criteria
Inclusion criteria: Patients = 18 years old that are fit for surgery and scheduled to undergo free flap surgery for reconstruction of a defect caused by oncological resection or trauma will be included.
Exclusion criteria
Exclusion criteria: Pregnancy or lactation; Participation in another fluorescence imaging study investigating ICG or a targeted optical imaging agent in the near-infrared fluorescence imaging wavelength (>650 nm) within one month prior to enrollment; A known severe hepatic or renal insufficiency; A history of hyperthyroidism; An autonomous thyroid adenoma; A history of allergic reactions to ICG or Iodine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter will be the ICG-derived fluorescence intensities during pre-, per- and post-operatively NIRF angiography. In addition, the other main study parameters are the HSI oxygenation values and thermal imaging skin temperature values observed during postoperative evaluation of the flap. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary paramters are the correlation between observerd fluorescence intensities, oxygenation values and local skin temperature with conventional diagnostic techniques and clinical outcomes. | — |
Contacts
Public ContactSimone Kleiss
UMCG
Outcome results
None listed