NCT03935139

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

5.4 years

First QC Date

April 30, 2019

Last Update Submit

July 9, 2024

Conditions

Flap Necrosis

Keywords

microdialysisbone free flapfibulailiac crest

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (12)

  • Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia

    every hour during the day of surgery

  • Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia

    every 2 hours at day 1 after surgery

  • 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

  • Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia

    every hour during the day of surgery

  • Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia

    every 2 hours at day 1 after surgery

  • +7 more secondary outcomes

Interventions

glucose measurementBIOLOGICAL

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 measurementBIOLOGICAL

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 measurementBIOLOGICAL

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 measurementBIOLOGICAL

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.

Bone free flap monitoringPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Interventions

Glycerol

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Stéphanie Dakpe, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Dakpe, MD

CONTACT

(33)322089050dakpe.stephanie@chu-amiens.fr

Sylvie Testelin, Pr

CONTACT

(33)322089050testelin.sylvie@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 2, 2019

Study Start

July 22, 2019

Primary Completion

December 1, 2024

Study Completion

July 1, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)