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MicrosurgeryMTMNCT01879384

Monitoring of Bone Free Flaps With Microdialysis

A study testing CMA 70 catheter directly positioned in bone tissue in people with Microsurgery and Head and Neck Reconstructive Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone flaps, and they all described the position of the catheter in the surrounding soft tissue muscle. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CMA 70 catheter directly positioned in bone tissue
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteFrance
Study dates
Feb 2011to Jun 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • head and neck reconstruction with iliac crest or fibula free flaps
  • informed consent obtained

Who cannot join

  • reconstruction with other types of free flaps

Trial locations and contacts

1 site in 1 country.

France1 site

  • Amiens University Hospital

    Amiens, Picardie, 80054

Other trials in France

About this study

Official title: Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue

Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone flaps, and they all described the position of the catheter in the surrounding soft tissue muscle. This surrounding soft tissue is not always the reflect of bone vascularisation.

The aim is to study the feasibility of a follow up of microanastomosed bone flaps with microdialysis. To reach this goal, investigators perform a clinical prospective research project untitled MTM project

Read the detailed description

In addition to our classical clinical monitoring, bone microanastomosed flaps for reconstructive facial surgery will be monitored with CMA 70 catheter directly positioned in bone tissue.

The monitoring is recorded during 5 days. Glucose, lactate , pyruvate , glycerol rates will be analysed :

  • every hour at day 1,
  • every two hours at day 2,
  • every three hours at day 3,4 and 5.

Data are managed with Labpilot software.

Being tested
CMA 70 catheter directly positioned in bone tissue
Keywords
microdialysis, bone free flap, head and neck, monitoring free flap, reconstructive surgery
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMA 70 catheter directly positioned in bone tissueDevice

    At the end of the surgery the CMA microdialysis catheter is placed inside the bone

Study groups in NCT01879384
Study groupRoleWhat they receive
Microdialysis with CMA 70 catheterExperimentalCMA 70 catheter directly positioned in bone tissue
Receives: Device: CMA 70 catheter directly positioned in bone tissue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)

    Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose.

    Measured: Day 5 after catheter insertion

Secondary outcomes (2)

  1. Evaluation of "flush-out" period

    Time required to acquire interpretable data after opening microdialysis circuit

    Measured: Day 5 after catheter insertion

  2. Compliance of the prescription

    Compliance rate of simples collected and analysed

    Measured: Day 5 after catheter insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2013 (estimated)
  2. Study startFeb 2011
  3. Primary completionMay 2013
  4. Study completionJun 2013

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01879384
Sponsor's protocol ID
PI08-PR-DEVAUCHELLE
Other IDs
2010-A01176-33
Acronym
MTM
Status last verified
Sep 2025
First submitted
13 Jun 2013
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No

Publications

  • Abdel-Galil K, Mitchell D. Postoperative monitoring of microsurgical free-tissue transfers for head and neck reconstruction: a systematic review of current techniques--part II. Invasive techniques. Br J Oral Maxillofac Surg. 2009 Sep;47(6):438-42. doi: 10.1016/j.bjoms.2008.12.002. Epub 2009 Jan 19.

    PubMed 19155107

  • Benacquista T, Kasabian AK, Karp NS. The fate of lower extremities with failed free flaps. Plast Reconstr Surg. 1996 Oct;98(5):834-40; discussion 841-2. doi: 10.1097/00006534-199610000-00013.

    PubMed 8823023

  • Birke-Sorensen H, Toft G, Bengaard J. Pure muscle transfers can be monitored by use of microdialysis. J Reconstr Microsurg. 2010 Nov;26(9):623-30. doi: 10.1055/s-0030-1267382. Epub 2010 Oct 6.

    PubMed 20927696

  • Bogehoj M, Emmeluth C, Overgaard S. Blood flow and microdialysis in the human femoral head. Acta Orthop. 2007 Feb;78(1):56-62. doi: 10.1080/17453670610013420.

    PubMed 17453393

  • Brix M, Muret P, Ricbourg B, Humbert P. [Monitoring free flaps with cutaneous microdialysis: preliminary study in oral cavity reconstruction]. Rev Stomatol Chir Maxillofac. 2006 Dec;107(6):460-4. doi: 10.1016/s0035-1768(06)77088-7. French.

    PubMed 17195000

  • Bui DT, Cordeiro PG, Hu QY, Disa JJ, Pusic A, Mehrara BJ. Free flap reexploration: indications, treatment, and outcomes in 1193 free flaps. Plast Reconstr Surg. 2007 Jun;119(7):2092-2100. doi: 10.1097/01.prs.0000260598.24376.e1.

    PubMed 17519706

  • Delgado JM, DeFeudis FV, Roth RH, Ryugo DK, Mitruka BM. Dialytrode for long term intracerebral perfusion in awake monkeys. Arch Int Pharmacodyn Ther. 1972;198(1):9-21. No abstract available.

    PubMed 4626478

  • Ferguson REH Jr, Yu P. Techniques of monitoring buried fasciocutaneous free flaps. Plast Reconstr Surg. 2009 Feb;123(2):525-532. doi: 10.1097/PRS.0b013e318196b9a3.

    PubMed 19182610

  • Holzle F, Rau A, Loeffelbein DJ, Mucke T, Kesting MR, Wolff KD. Results of monitoring fasciocutaneous, myocutaneous, osteocutaneous and perforator flaps: 4-year experience with 166 cases. Int J Oral Maxillofac Surg. 2010 Jan;39(1):21-8. doi: 10.1016/j.ijom.2009.10.012. Epub 2009 Nov 26.

    PubMed 19944567

  • Jallali N, Ridha H, Butler PE. Postoperative monitoring of free flaps in UK plastic surgery units. Microsurgery. 2005;25(6):469-72. doi: 10.1002/micr.20148.

    PubMed 16134095

  • Jyranki J, Suominen S, Vuola J, Back L. Microdialysis in clinical practice: monitoring intraoral free flaps. Ann Plast Surg. 2006 Apr;56(4):387-93. doi: 10.1097/01.sap.0000205231.39853.87.

    PubMed 16557069

  • Laure B, Sury F, Bayol JC, Goga D. [Microdialysis: experience in postoperative monitoring of 30 free flaps]. Ann Chir Plast Esthet. 2009 Feb;54(1):29-36. doi: 10.1016/j.anplas.2008.05.008. Epub 2008 Nov 29. French.

    PubMed 19042067

  • Mourouzis C, Anand R, Bowden JR, Brennan PA. Microdialysis: use in the assessment of a buried bone-only fibular free flap. Plast Reconstr Surg. 2007 Oct;120(5):1363-1366. doi: 10.1097/01.prs.0000279555.75241.4c. No abstract available.

    PubMed 17898613

  • Rojdmark J, Blomqvist L, Malm M, Adams-Ray B, Ungerstedt U. Metabolism in myocutaneous flaps studied by in situ microdialysis. Scand J Plast Reconstr Surg Hand Surg. 1998 Mar;32(1):27-34. doi: 10.1080/02844319850158921.

    PubMed 9556818

  • Setala L, Papp A, Romppanen EL, Mustonen P, Berg L, Harma M. Microdialysis detects postoperative perfusion failure in microvascular flaps. J Reconstr Microsurg. 2006 Feb;22(2):87-96. doi: 10.1055/s-2006-932502.

    PubMed 16456768

Questions about this trial

What is this clinical trial studying?

A study testing CMA 70 catheter directly positioned in bone tissue in people with Microsurgery and Head and Neck Reconstructive Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

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 1 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: finished, as of the sponsor's last update on 19 Sep 2025. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue) (time frame: Day 5 after catheter insertion). 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 NCT01879384, which also lists 20 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 19 Sep 2025.

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