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Efficacy Study of Free Flap Monitoring Using Capillary Lactate and Glucose Measurements

NCT01445990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2011-10-06

No results posted yet for this study

Summary

Evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments diagnosis in free tissue transfers is realized.

These measures are done after surgical reconstructions with free tissue flap, simultaneously with clinical examination. These biological data aren't available to make clinical diagnosis of complication; only clinical examination is allowed in this way.

A posteriori, clinical and biological parameters will be compared in order to determine if capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps monitoring.

Conditions

  • Postoperative Complications

Interventions

DEVICE

Lactate-meter: LactatePro (ARKRAY Inc)

Capillary glucose and lactate measurement. Every hours for the first 24 hours, and every 4 hours for the next 4 days.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    collaborator OTHER

  • Centre Hospitalier Universitaire, Amiens

    collaborator OTHER

  • Narcisse Zwetyenga

    lead OTHER

Principal Investigators

  • Benoit Henault, MD · Centre Hospitalier Universitaire Dijon

  • Narcisse Zwetyenga, PhD · Centre Hospitalier Universitaire Dijon

  • Julien Pauchot, MD · Centre Hospitalier Universitaire Dijon

  • Raphaël Sinna, MD · Centre Hospitalier Universitaire, Amiens

  • Christophe Meyer, PhD · Centre Hospitalier Universitaire, Besançon

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01445990 on ClinicalTrials.gov