Extracorporeal Perfusion of Microvascular Free Flaps

Technical University of Munich

Status: Unknown

Conditions: Complication of Perfusion; Perfusion

Treatments: Procedure: Perfusion of flaps by a special bypass system

Study type: Interventional

Funder types: Other

Identifiers

NCT02449525

MKG-ECP

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• active oncological disease
• vessels suitable for microvascular anastomosis and reconstruction

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

perfusion of flaps by a bypass system

Experimental group

Description:

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.

Treatment:

Procedure: Perfusion of flaps by a special bypass system