No registrations found.
ID
Source
Brief title
Health condition
Defects caused by oncological resection or trauma.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary paramters are the correlation between observerd fluorescence intensities, oxygenation values and local skin temperature with conventional diagnostic techniques and clinical outcomes.
Background summary
Adequate flap perfusion is crucial for reconstructive surgery success rates in order to restore function and normal appearance. Peri-operative feedback on flap design and postoperative monitoring of flap viability is known to be challenging, with limited accurate diagnostic imaging modalities available. Near-infrared fluorescence (NIRF) angiography with indocyanine green as dye that can visualize the cutaneous blood flow of the flap. In addition, post-operative flap viability can be determined with tissue perfusion measurement with techniques such as hyperspectral imaging and thermal imaging. In this study we want to determine the added value of NIRF angiography for peri-operative evaluation of flap design and free flap perfusion and subsequently the added value of hyperspectral imaging and thermal imaging for monitoring of free flap perfusion after reconstructive surgery.
Study objective
We hypothesize that NIRF angiography has added value for peri-operative evulation of flap design and free flap perfusion and subsequently we hypothesize that hyperspectral imaging and thermal imaging have added value for monitoring free flap perfusion after reconstructive surgery
Study design
Pre operatively , several times intraoperatively and twice daily post operatively untill discharge and once during post-op follow-up appointment.
Intervention
There will be no interventions in this study, it is an observational study
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8380 |
| Other | METC UMCG : METC2019457 |