Extracorporeal Perfusion of Microvascular Free Flaps

NCT ID: NCT02449525

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Perfusion Complication of Perfusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Perfusion of flaps by a special bypass system

Intervention Type PROCEDURE

Free flaps are perfused via a special bypass perfused by a new technique supported by a intermittent perfusion support system.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* active oncological disease
* vessels suitable for microvascular anastomosis and reconstruction
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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thomas.muecke

ECP Study

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus-Dietrich Wolff, Univ.-Prof.

Role: STUDY_DIRECTOR

Technical University of Munich

Locations

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Department of Oral and Maxillofacial Surgery, Technische Universität München

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Klaus-Dietrich Wolff, Univ.-Prof.

Role: CONTACT

0049(0)894140 2921

Thomas Mücke, Priv.-Doz.

Role: CONTACT

0049(0)894140 2921

Facility Contacts

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Klaus-Dietrich Wolff, Univ.-Prof.

Role: primary

Thomas Mücke, Priv.-Doz.

Role: backup

References

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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.

Reference Type DERIVED
PMID: 27756552 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26752222 (View on PubMed)

Other Identifiers

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MKG-ECP

Identifier Type: -

Identifier Source: org_study_id

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