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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Cagliari

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • University of Wisconsin solution + cold storage

    Device

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

  • Unperfused free flap under warm ischemia

    Other intervention

    Traditional processing of the free flap: no perfusion of the flap and warm ischemia (room temperature conservation during ischemia time

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: UWsolutionExperimental treatment 1 intervention
Group B: No perfusionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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),

Time frame
1 month
2

Rate of partial flap loss

Frequency of flaps that suffer from partial loss and are debrided

Time frame
1 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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