Clinical trial · Interventional
Monitoring of Bone Free Flaps With Microdialysis
Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Free Flap | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Reconstructive Surgery | — | UNRESOLVED | — |
| Head and/or Neck Shotgun Trauma | — | UNRESOLVED | — |
| Microsurgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMA 70 catheter directly positioned in bone tissue | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microdialysis with CMA 70 catheter
- description
- CMA 70 catheter directly positioned in bone tissue
- interventionNames
- Device: CMA 70 catheter directly positioned in bone tissue
Primary outcomes (1)
- measure
- Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)
- timeFrame
- Day 5 after catheter insertion
- description
- Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose.
Secondary outcomes (2)
- measure
- Evaluation of "flush-out" period
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * head and neck reconstruction with iliac crest or fibula free flaps * informed consent obtained Exclusion Criteria: * reconstruction with other types of free flaps
References
Publications (20)
- BACKGROUNDAbdel-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
- BACKGROUNDBenacquista 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
- BACKGROUNDBirke-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
- BACKGROUNDBogehoj 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
- BACKGROUNDBrix 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
- BACKGROUNDBui 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
- BACKGROUNDDelgado 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
- 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.