Extracorporeal Perfusion of Microvascular Free Flaps
Not Applicable
- Conditions
- Complication of PerfusionPerfusion
- Interventions
- Procedure: Perfusion of flaps by a special bypass system
- 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
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
- Arm && Interventions
Group Intervention Description perfusion of flaps by a bypass system Perfusion of flaps by a special 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.
- Primary Outcome Measures
Name Time Method Perfusion of Free Flap from wound bed Two Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Oral and Maxillofacial Surgery, Technische Universität München
🇩🇪Munich, Germany