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Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
Sponsor: Leiden University Medical Center
Summary
After some operations in which tissue is removed, it is necessary to repair the defect with a piece of tissue from another location in the body. This is called a microsurgically transplanted tissue flap (or tissue flap, for short). It is important that, after an operation, enough blood flows to the relocated tissue. In this study, we want to investigate whether, after the operation, measuring oxygen in the tissue flap with the INVOS 7100c device helps detect blood flow problems earlier. In the future, this could help doctors intervene more quickly, thereby reducing the risk of complications.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-12
Completion Date
2028-12
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Elective free flap surgery
Reconstruction using deep inferior epigastric perforator (DIEP) flap. Participants will receive standard surgical, anaesthetic and postoperative care according to local practice.
INVOS monitoring
The INVOS system (In Vivo Optical Spectroscopy). INVOS™ sensors will be applied to the free flap and to a femoral reference site for postoperative tissue oximetry monitoring. The INVOS™ monitor readings will not be visible to caregivers, alarms will be muted, and INVOS™ measurements will not be used for clinical decision-making during this study. Clinical assessment and Doppler monitoring will remain leading for all decisions regarding flap viability.
Locations (3)
Leiden University Medical Centre
Leiden, South Holland, Netherlands
Haaglanden Medisch Centrum, locatie Anthoniushove
Leidschendam, South Holland, Netherlands
HagaZiekenhuis
The Hague, South Holland, Netherlands