About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Post-oncological mandible reconstruction through fibula free flap,
Post-oncological soft tissue reconstruction through ALT (Anterior Lateral Thigh) free flap in head and neck region
Post-oncological breast reconstruction through DIEP (Deep Inferior Epigastric Perforator) and PAP (Profunda femoris Artery Perforator) free flaps.
Disqualifiers
Malnutrition
Malabsorption
Vasculitis
Pathologies of the connective tissue
Trial design
Parallel
Treatments tested in this trial
University of Wisconsin solution + cold storage
DevicePreservation of the free flap with UW solution and cold storage during ischemia time
Unperfused free flap under warm ischemia
Other interventionTraditional processing of the free flap: no perfusion of the flap and warm ischemia (room temperature conservation during ischemia time
Treatment groups
Trial outcomes
Primary outcomes
Rate of total flap loss
Frequency of flaps that suffer from complete loss and are removed evaluated through fluorescence after the injection of indocyanine green by means of SPY PHI (Portable Handheld Imager) by Stryker (Kalamazoo, USA),
Rate of partial flap loss
Frequency of flaps that suffer from partial loss and are debrided
Locations
Sponsors and contacts
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