Monitoring bone free flaps using microdialysis
Monitoring of the Bone Free Flaps With Microdialysis
This study is testing a new way to monitor bone flaps used in facial surgery by checking the levels of certain substances in the tissue to see if it helps prevent complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT03935139 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the monitoring of bone free flaps used in facial reconstructive surgery by utilizing microdialysis catheters placed directly in the bone tissue. The focus is on determining the mean lactate/pyruvate ratio, which can provide critical insights into the vascularization of the flaps. Given the high failure rates of these procedures, this method could enhance the accuracy of monitoring and potentially reduce complications. The study will involve measuring glucose, lactate, pyruvate, and glycerol levels in patients undergoing head and neck reconstruction with iliac crest or fibula free flaps.
Who should consider this trial
Good fit: Ideal candidates include adults undergoing head and neck reconstruction with iliac crest or fibula free flaps who can provide informed consent.
Not a fit: Patients who are minors, pregnant or breastfeeding, or those receiving other types of free flaps will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of flap necrosis and improve outcomes for patients undergoing reconstructive surgery.
How similar studies have performed: While microdialysis has been used in various surgical contexts, this specific application in bone free flaps is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Principal investigator: Stéphanie Dakpe, MD — CHU Amiens
- Study coordinator: Stéphanie Dakpe, MD
- Email: dakpe.stephanie@chu-amiens.fr
- Phone: (33)322089050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.