Extracorporeal Perfusion of Microvascular Free Flaps

Perfusion Clinical Trial

Official title:

Extracorporal Perfusion of Free Flaps in the Head and Neck

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02449525
• Other study ID #: MKG-ECP
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2015
• Last updated: March 7, 2016
• Start date: June 2013
• Est. completion date: May 2018

Study information

• Verified date: March 2016
• Source: Technische Universität München
• Contact: Klaus-Dietrich Wolff, Univ.-Prof.
• Phone: 0049(0)894140 2921
• Email: wolff[@]mkg.med.tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Perfusion
• Perfusion

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Oral and Maxillofacial Surgery, Technische Universität München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion of Free Flap from wound bed		Two Weeks	No