Monitoring of tissue perfusion during reconstructive free flap surgery
- Conditions
- Defects caused by oncological resection or trauma.
- Registration Number
- NL-OMON29325
- Lead Sponsor
- none
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary paramters are the correlation between observerd fluorescence intensities, oxygenation values and local skin temperature with conventional diagnostic techniques and clinical outcomes.