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Status unknownNCT02449525Updated Mar 8, 2016

Extracorporeal Perfusion of Microvascular Free Flaps

An interventional study of Perfusion of flaps by a special bypass system in Perfusion and Complication of Perfusion, sponsored by Technical University of Munich. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-03-08.

Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Perfusion
  • Complication of Perfusion
03

In context

Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • active oncological disease
  • vessels suitable for microvascular anastomosis and reconstruction
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedurePerfusion 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.

06

What researchers measure

Primary outcomes

  1. Perfusion of Free Flap from wound bed

    Time frame: Two Weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Oral and Maxillofacial Surgery, Technische Universität München
    Munich, 81675, Germany
    Recruiting
08

References and documents

Publications

  • Fichter AM, Ritschl LM, Rau A, Schwarzer C, von Bomhard A, Wagenpfeil S, Wolff KD, Mucke T. Free flap rescue using an extracorporeal perfusion device. J Craniomaxillofac Surg. 2016 Dec;44(12):1889-1895. doi: 10.1016/j.jcms.2016.09.010. Epub 2016 Sep 23. PubMed 27756552 ↗
  • Wolff KD, Mucke T, von Bomhard A, Ritschl LM, Schneider J, Humbs M, Fichter AM. Free flap transplantation using an extracorporeal perfusion device: First three cases. J Craniomaxillofac Surg. 2016 Feb;44(2):148-54. doi: 10.1016/j.jcms.2015.11.007. Epub 2015 Dec 1. PubMed 26752222 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02449525
Lead sponsor
Technical University of Munich
Responsible party
thomas.muecke (ECP Study, Technical University of Munich) — Principal investigator
First posted
May 20, 2015
Start date
Jun 2013
Primary completion
May 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Mar 8, 2016

Study contacts

Klaus-Dietrich Wolff, Univ.-Prof.
Contact
wolff@mkg.med.tum.de
0049(0)894140 2921
Thomas Mücke, Priv.-Doz.
Contact
th.mucke@gmx.de
0049(0)894140 2921
Klaus-Dietrich Wolff, Univ.-Prof.
study director · Technical University of Munich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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