MTM: Monitoring of Bone Free Flaps With Microdialysis
Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT01879384
Collaborator
Regional Council Picardie (Other)
34
1
1
28
1.2
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue
Study Start Date
:
Feb 1, 2011
Actual Primary Completion Date
:
May 1, 2013
Actual Study Completion Date
:
Jun 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Microdialysis with CMA 70 catheter CMA 70 catheter directly positioned in bone tissue |
Device: CMA 70 catheter directly positioned in bone tissue
At the end of the surgery the CMA microdialysis catheter is placed inside the bone
|
Outcome Measures
Primary Outcome Measures
- Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue) [Day 5 after catheter insertion]
Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose.
Secondary Outcome Measures
- Evaluation of "flush-out" period [Day 5 after catheter insertion]
Time required to acquire interpretable data after opening microdialysis circuit
- Compliance of the prescription [Day 5 after catheter insertion]
Compliance rate of simples collected and analysed
Other Outcome Measures
- Delay of ischemia detection with metabolic parameters, compared to clinical symptoms [from implantation time day 5]
Time between the occurrence of the first metabolic changes and the first clinical signs of tissue damage
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Amiens University Hospital | Amiens | Picardie | France | 80054 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire, Amiens
- Regional Council Picardie
Investigators
- Principal Investigator: Bernard DEVAUCHELLE, MD, phD, Amiens University Hospital
Study Documents (Full-Text)
None provided.More Information
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. Review.
- 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.
- 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.
- Bøgehøj M, Emmeluth C, Overgaard S. Blood flow and microdialysis in the human femoral head. Acta Orthop. 2007 Feb;78(1):56-62.
- 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.
- 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.
- 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.
- 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.
- 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.
- Jallali N, Ridha H, Butler PE. Postoperative monitoring of free flaps in UK plastic surgery units. Microsurgery. 2005;25(6):469-72.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Review.
- 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.
- Ungerstedt U, Rostami E. Microdialysis in neurointensive care. Curr Pharm Des. 2004;10(18):2145-52. Review.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01879384
Other Study ID Numbers:
- PI08-PR-DEVAUCHELLE
- 2010-A01176-33
First Posted:
Jun 17, 2013
Last Update Posted:
Aug 10, 2018
Last Verified:
Aug 1, 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms: