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

NCT06523920 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-26

No results posted yet for this study

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.

Conditions

  • Ischemia Reperfusion Injury

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

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Principal Investigators

  • Adriana Cordova, Prof · University of Palermo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-06-30
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06523920 on ClinicalTrials.gov