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NOT YET RECRUITING
NCT06523920
NA

Protecting Autologous Free Flaps From Ischemia/Reperfusion Damage With Cold Storage.

Sponsor: University of Cagliari

View on ClinicalTrials.gov

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

Interventions

DEVICE

University of Wisconsin solution + cold storage

Preservation of the free flap with UW solution and cold storage during ischemia time

OTHER

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