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Protecting Autologous Free Flaps From Ischemia/Reperfusion Damage With Cold Storage.
Sponsor: University of Cagliari
Summary
Reconstructive microsurgery allows autologous transplantation of flaps. The procedure causes temporary ischemia. The absence of perfusion and the post-anastomosis reperfusion causes ischemia/reperfusion (I/R) damage and an increased percentage of flap complications associated with the longer duration of the ischemia time. In reconstructive surgery the utilization of preservation solution is very limited. The research hypothesis is that cold storage of free flaps might offer benefits. The present study is a RCT to evaluate the feasibility and safety of a cold preservation (using the UW solution) of the free flaps from I/R damage in oncological microsurgical reconstructions. Blood perfusion will be intraoperatively evaluated through indocyanine green and SPY-DHI. Moreover, patients' outcomes will be evaluated postoperatively through clinical and radiological examinations, particularly focusing on somatosensory recovery and dental rehabilitation after mandibular reconstruction.
Official title: Protecting Autologous Free Flaps From Ischemia/Reperfusion Damage With Cold Storage: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-08-01
Completion Date
2026-06-30
Last Updated
2024-07-26
Healthy Volunteers
No
Conditions
Interventions
University of Wisconsin solution + cold storage
Preservation of the free flap with UW solution and cold storage during ischemia time
Unperfused free flap under warm ischemia
Traditional processing of the free flap: no perfusion of the flap and warm ischemia (room temperature conservation during ischemia time