Monitoring of Bone Free Flaps With Microdialysis

Head and Neck Cancer Clinical Trial

— MTM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879384
• Other study ID #: PI08-PR-DEVAUCHELLE
• Secondary ID: 2010-A01176-33
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• CMA 70 catheter directly positioned in bone tissue
At the end of the surgery the CMA microdialysis catheter is placed inside the bone

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens	Picardie

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Regional Council Picardie

Country where clinical trial is conducted

France, 

References & Publications (19)

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. Review. — View Citation

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. — View Citation

Birke-Sørensen 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. — View Citation

Bøgehøj M, Emmeluth C, Overgaard S. Blood flow and microdialysis in the human femoral head. Acta Orthop. 2007 Feb;78(1):56-62. — View Citation

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. French. — View Citation

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):2092-100. — View Citation

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. — View Citation

Ferguson RE Jr, Yu P. Techniques of monitoring buried fasciocutaneous free flaps. Plast Reconstr Surg. 2009 Feb;123(2):525-32. doi: 10.1097/PRS.0b013e318196b9a3. — View Citation

Hölzle F, Rau A, Loeffelbein DJ, Mücke 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. — View Citation

Jallali N, Ridha H, Butler PE. Postoperative monitoring of free flaps in UK plastic surgery units. Microsurgery. 2005;25(6):469-72. — View Citation

Jyränki J, Suominen S, Vuola J, Bäck L. Microdialysis in clinical practice: monitoring intraoral free flaps. Ann Plast Surg. 2006 Apr;56(4):387-93. — View Citation

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. — View Citation

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):1363-6. — View Citation

Röjdmark 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. — View Citation

Setälä L, Papp A, Romppanen EL, Mustonen P, Berg L, Härmä M. Microdialysis detects postoperative perfusion failure in microvascular flaps. J Reconstr Microsurg. 2006 Feb;22(2):87-96. — View Citation

Setälä LP, Korvenoja EM, Härmä 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. — View Citation

Smit JM, Zeebregts CJ, Acosta R, Werker PM. Advancements in free flap monitoring in the last decade: a critical review. Plast Reconstr Surg. 2010 Jan;125(1):177-85. doi: 10.1097/PRS.0b013e3181c49580. Review. — View Citation

Stolle LB, Arpi M, Jørgensen 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. — View Citation

Ungerstedt U, Rostami E. Microdialysis in neurointensive care. Curr Pharm Des. 2004;10(18):2145-52. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delay of ischemia detection with metabolic parameters, compared to clinical symptoms	Time between the occurrence of the first metabolic changes and the first clinical signs of tissue damage	from implantation time day 5
Primary	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	Evaluation of "flush-out" period	Time required to acquire interpretable data after opening microdialysis circuit	Day 5 after catheter insertion
Secondary	Compliance of the prescription	Compliance rate of simples collected and analysed	Day 5 after catheter insertion