Monitoring of the Bone Free Flaps With Microdialysis

NCT ID: NCT03935139

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Flap Necrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Bone free flap monitoring

Bone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphanie Dakpe, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stéphanie Dakpe, MD

Role: CONTACT

(33)322089050

Sylvie Testelin, Pr

Role: CONTACT

(33)322089050

Facility Contacts

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Stéphanie Dakpe, MD

Role: primary

(33)322089050

Sylvie Testelin, Pr

Role: backup

(33)322089050

Other Identifiers

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PI2018_843_0023

Identifier Type: -

Identifier Source: org_study_id

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