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Monitoring of Bone Free Flaps With Microdialysis (MTM)

Primary Purpose

Microsurgery, Head and Neck Reconstructive Surgery, Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CMA 70 catheter directly positioned in bone tissue
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Microsurgery focused on measuring microdialysis, bone free flap, head and neck, monitoring free flap, reconstructive surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amiens University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microdialysis with CMA 70 catheter

Arm Description

CMA 70 catheter directly positioned in bone tissue

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluation of "flush-out" period
Time required to acquire interpretable data after opening microdialysis circuit
Compliance of the prescription
Compliance rate of simples collected and analysed

Full Information

First Posted
June 13, 2013
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Regional Council Picardie
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1. Study Identification

Unique Protocol Identification Number
NCT01879384
Brief Title
Monitoring of Bone Free Flaps With Microdialysis
Acronym
MTM
Official Title
Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Regional Council Picardie

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microdialysis with CMA 70 catheter
Arm Type
Experimental
Arm Description
CMA 70 catheter directly positioned in bone tissue
Intervention Type
Device
Intervention Name(s)
CMA 70 catheter directly positioned in bone tissue
Intervention Description
At the end of the surgery the CMA microdialysis catheter is placed inside the bone
Primary Outcome Measure Information:
Title
Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)
Description
Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose.
Time Frame
Day 5 after catheter insertion
Secondary Outcome Measure Information:
Title
Evaluation of "flush-out" period
Description
Time required to acquire interpretable data after opening microdialysis circuit
Time Frame
Day 5 after catheter insertion
Title
Compliance of the prescription
Description
Compliance rate of simples collected and analysed
Time Frame
Day 5 after catheter insertion
Other Pre-specified Outcome Measures:
Title
Delay of ischemia detection with metabolic parameters, compared to clinical symptoms
Description
Time between the occurrence of the first metabolic changes and the first clinical signs of tissue damage
Time Frame
from implantation time day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard DEVAUCHELLE, MD, phD
Organizational Affiliation
Amiens University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19155107
Citation
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.
Results Reference
background
PubMed Identifier
8823023
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. doi: 10.1097/00006534-199610000-00013.
Results Reference
background
PubMed Identifier
20927696
Citation
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.
Results Reference
background
PubMed Identifier
17453393
Citation
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.
Results Reference
background
PubMed Identifier
17195000
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. doi: 10.1016/s0035-1768(06)77088-7. French.
Results Reference
background
PubMed Identifier
17519706
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):2092-2100. doi: 10.1097/01.prs.0000260598.24376.e1.
Results Reference
background
PubMed Identifier
4626478
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. No abstract available.
Results Reference
background
PubMed Identifier
19182610
Citation
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.
Results Reference
background
PubMed Identifier
19944567
Citation
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.
Results Reference
background
PubMed Identifier
16134095
Citation
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.
Results Reference
background
PubMed Identifier
16557069
Citation
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.
Results Reference
background
PubMed Identifier
19042067
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.
Results Reference
background
PubMed Identifier
17898613
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):1363-1366. doi: 10.1097/01.prs.0000279555.75241.4c. No abstract available.
Results Reference
background
PubMed Identifier
9556818
Citation
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.
Results Reference
background
PubMed Identifier
16456768
Citation
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.
Results Reference
background
PubMed Identifier
15160382
Citation
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.
Results Reference
background
PubMed Identifier
20048610
Citation
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.
Results Reference
background
PubMed Identifier
14620985
Citation
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.
Results Reference
background
PubMed Identifier
15281890
Citation
Ungerstedt U, Rostami E. Microdialysis in neurointensive care. Curr Pharm Des. 2004;10(18):2145-52. doi: 10.2174/1381612043384105.
Results Reference
background

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Monitoring of Bone Free Flaps With Microdialysis

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