Extracorporeal Perfusion of Microvascular Free Flaps
Extracorporal Perfusion of Free Flaps in the Head and Neck
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 8, 2016
March 1, 2016
4.9 years
May 11, 2015
March 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Perfusion of Free Flap from wound bed
Two Weeks
Study Arms (1)
perfusion of flaps by a bypass system
EXPERIMENTALSupport 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.
Interventions
Free flaps are perfused via a special bypass perfused by a new technique supported by a intermittent perfusion support system.
Eligibility Criteria
You may qualify if:
- Vessel depleted neck
- defect in the head and neck area
You may not qualify if:
- active oncological disease
- vessels suitable for microvascular anastomosis and reconstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oral and Maxillofacial Surgery, Technische Universität München
Munich, 81675, Germany
Related Publications (2)
Fichter AM, Ritschl LM, Rau A, Schwarzer C, von Bomhard A, Wagenpfeil S, Wolff KD, Mucke T. Free flap rescue using an extracorporeal perfusion device. J Craniomaxillofac Surg. 2016 Dec;44(12):1889-1895. doi: 10.1016/j.jcms.2016.09.010. Epub 2016 Sep 23.
PMID: 27756552DERIVEDWolff KD, Mucke T, von Bomhard A, Ritschl LM, Schneider J, Humbs M, Fichter AM. Free flap transplantation using an extracorporeal perfusion device: First three cases. J Craniomaxillofac Surg. 2016 Feb;44(2):148-54. doi: 10.1016/j.jcms.2015.11.007. Epub 2015 Dec 1.
PMID: 26752222DERIVED
Study Officials
- STUDY DIRECTOR
Klaus-Dietrich Wolff, Univ.-Prof.
Technical University of Munich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ECP Study
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 20, 2015
Study Start
June 1, 2013
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
March 8, 2016
Record last verified: 2016-03