Extracorporeal Perfusion of Microvascular Free Flaps

Not Applicable

• Conditions: Complication of Perfusion; Perfusion

• Registration Number: NCT02449525
• Lead Sponsor: Technical University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-20
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Perfusion of Free Flap from wound bed	Two Weeks

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Surgery, Technische Universität München; 🇩🇪 Munich, Germany