Extracorporeal Perfusion of Microvascular Free Flaps

March 7, 2016 updated by: thomas.muecke, Technical University of Munich

Extracorporal Perfusion of Free Flaps in the Head and Neck

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81675
        • Recruiting
        • Department of Oral and Maxillofacial Surgery, Technische Universität München
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Vessel depleted neck
  • defect in the head and neck area

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Study Director: Klaus-Dietrich Wolff, Univ.-Prof., Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 20, 2015

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • MKG-ECP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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