Monitoring of the Bone Free Flaps With Microdialysis

Flap Necrosis Clinical Trial

— MTM2018  

Official title:

Monitoring of the Bone Free Flaps With Microdialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03935139
• Other study ID #: PI2018_843_0023
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: July 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Stéphanie Dakpe, MD
• Phone: (33)322089050
• Email: dakpe.stephanie[@]chu-amiens.fr
• 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 free flaps, and they all describe the position of the catheter in the surrounding soft tissue muscle which is not the accurate reflect of bone vascularisation. The aim of this study is to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.

Description:

Failure rate of facial reconstructive surgery with bone free flaps varies between 11 and 25%. In case of buried bone free flaps, the follow up is even more difficult. Monitoring methods, such as the implantable Doppler system, laser Doppler flowmetry and microdialysis have been developped in the last 15 years. Ferguson et al. show a false positive rate of 31% with implantable doppler monitoring of buried flaps. The purpose of this study is to to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult person
• signed informed consent
• head and neck reconstruction with iliac crest or fibula free flap
• patient covered by national health insurance

Exclusion Criteria:

• minor person
• head and neck reconstruction with other types of free flaps than crest or fibula free flap
• pregnant or breastfeeding women

Related Conditions & MeSH terms

• Flap Necrosis
• Necrosis

Intervention

Biological:
• glucose measurement
Glucose values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.
• lactacte measurement
Lactate values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.
• pyruvate measurement
pyruvate values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.
• glycerol measurement
glycerol values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.

Procedure:
• Bone free flap monitoring
Bone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	every hour during the day of surgery
Primary	Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	every 2 hours at day 1 after surgery
Primary	Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	every 3 hours at days 2, 3 , 4 and 5 after surgery
Secondary	Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia	every hour during the day of surgery
Secondary	Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia	every 2 hours at day 1 after surgery
Secondary	Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia	every 3 hours at days 2, 3 , 4 and 5 after surgery
Secondary	Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia	every hour during the day of surgery
Secondary	Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia	every 2 hours at day 1 after surgery
Secondary	Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia	every 3 hours at days 2, 3 , 4 and 5 after surgery
Secondary	Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia	every hour during the day of surgery
Secondary	Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients with crest free flap ischemia	every 2 hours at day 1 after surgery
Secondary	Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients with crest free flap ischemia	every 3 hours at days 2, 3 , 4 and 5 after surgery
Secondary	Change from Baseline of metabolites rate in patients with free flap ischemia	Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.	every hour during the day of surgery
Secondary	Change from Baseline of metabolites rate in patients with free flap ischemia	Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.	every 2 hours at day 1 after surgery
Secondary	Change from Baseline of metabolites rate in patients with free flap ischemia	Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.	every 3 hours at days 2, 3 , 4 and 5 after surgery