Extracorporal Perfusion of Free Flaps in the Head and Neck
| Registry | NCT02449525 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 10 (Estimated) |
| Sponsor | Technical University of Munich (Other) |
| Conditions | Perfusion, Complication of Perfusion |
| Interventions | Perfusion of flaps by a special bypass system (Procedure) |
| Dates | start 2013-06-01, primary completion 2018-05-01 (estimated), completion 2018-05-01 (estimated), first posted 2015-05-20, last updated 2016-03-08 |
| Locations | 1 site in Germany |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| perfusion of flaps by a bypass system | Experimental | Procedure: 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. |
Sex: All, ages: 18 Years to 100 Years
Inclusion Criteria: * Vessel depleted neck * defect in the head and neck area Exclusion Criteria: * active oncological disease * vessels suitable for microvascular anastomosis and reconstruction
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Oral and Maxillofacial Surgery, Technische Universität München | Munich | Germany | Recruiting |