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

NCT06523920 | Not Yet Recruiting

• 1 other identifier: MUR: P2022EEZ8R
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

free flap; microsurgery; cold ischemia

Outcome Measures

Primary Outcomes (2)

• 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),

  1 month

• Rate of partial flap loss

  Frequency of flaps that suffer from partial loss and are debrided

  1 month

Study Arms (2)

UWsolution

EXPERIMENTAL

Flap preserved in UW solution and cold storage during the ischemia time

Device: University of Wisconsin solution + cold storage

No perfusion

SHAM COMPARATOR

Flap without perfusion and cold storage

Other: Unperfused free flap under warm ischemia

Interventions

University of Wisconsin solution + cold storage DEVICE

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

UWsolution

Unperfused free flap under warm ischemia OTHER

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

No perfusion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Malnutrition
• Malabsorption
• Vasculitis
• Pathologies of the connective tissue

Sponsors & Collaborators

• University of Cagliari: lead

Related Publications (25)

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MeSH Terms

Conditions

Reperfusion Injury

Interventions

Cryopreservation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Study Officials

• Adriana Cordova, Prof

  University of Palermo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filippo Boriani, Prof

CONTACT

+393297604660; borianifilippo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share