NCT01445990

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

4 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2011

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

1.7 years

First QC Date

September 30, 2011

Last Update Submit

October 5, 2011

Conditions

Postoperative Complications

Keywords

free tissue flapslactic acidglucosethrombosisdiagnostic testPedicle postoperative complications diagnosis

Outcome Measures

Primary Outcomes (1)

  • Clinical examination of the flap

    Clinical examination is done immediately after the end of the surgical procedure (Expected 1 to 5 hours after the end of arterial anastomosis). Then, examinations are done every hours for the first 24 hours, and every 4 hours for the next 4 days. The clinical examination was standardized: skin paddle colour and temperature, skin reperfusion time, and bleeding test with a prick. In order to avoid bias, examinations are performed by caregivers before capillary lactate and glucose measurements, and they hadn't any information about expected results of lactate and glucose values.

    Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose and lactate measurements.

Secondary Outcomes (2)

  • Capillary lactate measurements

    Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose measurements and clinical examinations.

  • Capillary glucose measurements

    Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary lactate measurements and clinical examinations.

Interventions

Lactate-meter: LactatePro (ARKRAY Inc)DEVICE

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

Eligibility Criteria

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

You may qualify if:

  • Informed patient
  • Signed informed consent
  • Free tissue flap reconstruction
  • Accessible flap for measurements

You may not qualify if:

  • Pregnancy
  • Patient under 18
  • Unaccessible flap

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens

Amiens, 80000, France

Location

Maxillo-Facial Surgery, Besancon Univestitary Hospital

Besançon, 25000, France

Location

Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital

Besançon, 25000, France

Location

Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire

Dijon, 21000, France

Location

MeSH Terms

Conditions

Postoperative ComplicationsThrombosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Benoit Henault, MD

    Centre Hospitalier Universitaire Dijon

    STUDY CHAIR

  • Narcisse Zwetyenga, PhD

    Centre Hospitalier Universitaire Dijon

    PRINCIPAL INVESTIGATOR

  • Julien Pauchot, MD

    Centre Hospitalier Universitaire Dijon

    STUDY CHAIR

  • Raphaël Sinna, MD

    Centre Hospitalier Universitaire, Amiens

    STUDY CHAIR

  • Christophe Meyer, PhD

    Centre Hospitalier Universitaire, Besançon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Maxillo-Facial, Plastic and Reconstructive Surgery Unit

Study Record Dates

First Submitted

September 30, 2011

First Posted

October 4, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

FR(4)