PerfusionNCT02449525
Extracorporeal Perfusion of Microvascular Free Flaps
A study testing Perfusion of flaps by a special bypass system in people with Perfusion and Complication of Perfusion, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Perfusion, Complication of Perfusion
- What is being tested?
- Perfusion of flaps by a special bypass system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vessel depleted neck
- defect in the head and neck area
Who cannot join
- active oncological disease
- vessels suitable for microvascular anastomosis and reconstruction
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Oral and Maxillofacial Surgery, Technische Universität München
Munich, 81675
Klaus-Dietrich Wolff, Univ.-Prof., wolff@mkg.med.tum.de
Thomas Mücke, Priv.-Doz., th.mucke@gmx.de
About this study
Official title: Extracorporal Perfusion of Free Flaps in the Head and Neck
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.
- Conditions
- Perfusion, Complication of Perfusion
- Being tested
- Perfusion of flaps by a special bypass system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion of flaps by a special bypass systemProcedure or surgery
Free flaps are perfused via a special bypass perfused by a new technique supported by a intermittent perfusion support system.
| Study group | Role | What they receive |
|---|---|---|
| perfusion of flaps by a bypass system | Experimental | 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. Receives: Procedure: Perfusion of flaps by a special bypass system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion of Free Flap from wound bed
Measured: Two Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJun 2013
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PerfusionStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, thomas.muecke, Technical University of Munich
- Investigators
- Klaus-Dietrich Wolff, Univ.-Prof., Study director, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449525
- Sponsor's protocol ID
- MKG-ECP
- Status last verified
- Mar 2016
- First submitted
- 11 May 2015
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27756552Wolff 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.
PubMed 26752222
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporal Perfusion of Free Flaps in the Head and Neck
- ClinicalTrials.gov ID
- NCT02449525
- Acronym / sponsor ID
- MKG-ECP
- Conditions
- Perfusion, Complication of Perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| perfusion of flaps by a bypass system | Experimental | Procedure: Perfusion of flaps by a special bypass systemSupport 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vessel depleted neck
- defect in the head and neck area
Key exclusion criteria (2 listed)
- active oncological disease
- vessels suitable for microvascular anastomosis and reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perfusion of flaps by a special bypass systemFree flaps are perfused via a special bypass perfused by a new technique supported by a intermittent perfusion support system. | Procedure or surgery | perfusion of flaps by a bypass system |
Primary outcome
Perfusion of Free Flap from wound bed
Time frame: Two Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Derived from this study: PubMed 27756552Fichter 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.
- Derived from this study: PubMed 26752222Wolff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus-Dietrich Wolff, Univ.-Prof. study director
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perfusion of flaps by a special bypass system in people with Perfusion and Complication of Perfusion, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus-Dietrich Wolff, Univ.-Prof. (0049(0)894140 2921, wolff@mkg.med.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion of Free Flap from wound bed (time frame: Two Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02449525, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.