Monitoring of Bone Free Flaps With Microdialysis

NCT01879384 | Completed

• 2 other identifiers: PI08-PR-DEVAUCHELLE2010-A01176-33
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Microsurgery; Head and Neck Reconstructive Surgery; Head and Neck Cancer; Head and/or Neck Shotgun Trauma; Bone Free Flap

Keywords

microdialysis; bone free flap; head and neck; monitoring free flap; reconstructive surgery

Outcome Measures

Primary Outcomes (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.

  Day 5 after catheter insertion

Secondary Outcomes (2)

• Evaluation of "flush-out" period

  Day 5 after catheter insertion

• Compliance of the prescription

  Day 5 after catheter insertion

Other Outcomes (1)

• Delay of ischemia detection with metabolic parameters, compared to clinical symptoms

  from implantation time day 5

Study Arms (1)

Microdialysis with CMA 70 catheter

EXPERIMENTAL

CMA 70 catheter directly positioned in bone tissue

Device: CMA 70 catheter directly positioned in bone tissue

Interventions

CMA 70 catheter directly positioned in bone tissue DEVICE

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

Microdialysis with CMA 70 catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• reconstruction with other types of free flaps

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Regional Council Picardie: collaborator

Study Sites (1)

Amiens University Hospital

Amiens, Picardie, 80054, France

Location

Related Publications (20)

• 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.

  PMID: 19155107 BACKGROUND

• 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.

  PMID: 8823023 BACKGROUND

• 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.

  PMID: 20927696 BACKGROUND

• 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.

  PMID: 17453393 BACKGROUND

• 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.

  PMID: 17195000 BACKGROUND

• 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.

  PMID: 17519706 BACKGROUND

• 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.

  PMID: 4626478 BACKGROUND

• 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.

  PMID: 19182610 BACKGROUND

• 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.

  PMID: 19944567 BACKGROUND

• 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.

  PMID: 16134095 BACKGROUND

• 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.

  PMID: 16557069 BACKGROUND

• 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.

  PMID: 19042067 BACKGROUND

• 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.

  PMID: 17898613 BACKGROUND

• 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.

  PMID: 9556818 BACKGROUND

• 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.

  PMID: 16456768 BACKGROUND

• Setala LP, Korvenoja EM, Harma MA, Alhava EM, Uusaro AV, Tenhunen JJ. Glucose, lactate, and pyruvate response in an experimental model of microvascular flap ischemia and reperfusion: a microdialysis study. Microsurgery. 2004;24(3):223-31. doi: 10.1002/micr.20045.

  PMID: 15160382 BACKGROUND

• Smit JM, Zeebregts CJ, Acosta R, Werker PMN. Advancements in free flap monitoring in the last decade: a critical review. Plast Reconstr Surg. 2010 Jan;125(1):177-185. doi: 10.1097/PRS.0b013e3181c49580.

  PMID: 20048610 BACKGROUND

• Stolle LB, Arpi M, Jorgensen PH, Riegels-Nielsen P, Keller J. In situ gentamicin concentrations in cortical bone: an experimental study using microdialysis in bone. Acta Orthop Scand. 2003 Oct;74(5):611-6. doi: 10.1080/00016470310018045.

  PMID: 14620985 BACKGROUND

• Ungerstedt U, Rostami E. Microdialysis in neurointensive care. Curr Pharm Des. 2004;10(18):2145-52. doi: 10.2174/1381612043384105.

  PMID: 15281890 BACKGROUND

• Dakpe S, Colin E, Bettoni J, Davrou J, Diouf M, Devauchelle B, Testelin S. Intraosseous microdialysis for bone free flap monitoring in head and neck reconstructive surgery: A prospective pilot study. Microsurgery. 2020 Mar;40(3):315-323. doi: 10.1002/micr.30529. Epub 2019 Oct 22.

  PMID: 31638286 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Bernard DEVAUCHELLE, MD, phD

  Amiens University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 17, 2013
• Study Start: February 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (1)