Extracorporeal Perfusion of Microvascular Free Flaps

Overview

The perfusion of microvascular free flaps is inevitable for completion of reconstruction in the head and neck area. In some patients microvascular anastomosis is impossible because of arteriosclerotic changes, different oncological interventions, and consecutive vessel depletion at the neck. The aim of the project is to establish an innovative system for extracorporeal perfusion of microvascular free flaps after ingrowth of new vessels from the wound bed have taken place. Afterwards, no further perfusion of the vascular pedicle is required for free flaps to survive and provide functional and aesthetic reconstruction.

Full Title of Study: “Extracorporal Perfusion of Free Flaps in the Head and Neck”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2018

Interventions

  • Procedure: Perfusion of flaps by a special bypass system
    • Free flaps are perfused via a special bypass perfused by a new technique supported by a intermittent perfusion support system.

Arms, Groups and Cohorts

  • Experimental: perfusion of flaps by a bypass system
    • Support of perfusion of microvascular free flaps until ingrowth of vessels from the wound bed has taken place. The System works with a pressure controlled bypass to ensure low grade perfusion.

Clinical Trial Outcome Measures

Primary Measures

  • Perfusion of Free Flap from wound bed
    • Time Frame: Two Weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Vessel depleted neck – defect in the head and neck area Exclusion Criteria:

  • active oncological disease – vessels suitable for microvascular anastomosis and reconstruction

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technische Universität München
  • Provider of Information About this Clinical Study
    • Principal Investigator: thomas.muecke, ECP Study – Technische Universität München
  • Overall Official(s)
    • Klaus-Dietrich Wolff, Univ.-Prof., Study Director, Technische Universität München
  • Overall Contact(s)
    • Klaus-Dietrich Wolff, Univ.-Prof., 0049(0)894140 2921, wolff@mkg.med.tum.de

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