Postoperative ComplicationsNCT01445990
Efficacy Study of Free Flap Monitoring Using Capillary Lactate and Glucose Measurements
A study testing Lactate-meter: LactatePro (ARKRAY Inc) in people with Postoperative Complications, run by Narcisse Zwetyenga at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Lactate-meter: LactatePro (ARKRAY Inc)
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed patient
- Signed informed consent
- Free tissue flap reconstruction
- Accessible flap for measurements
Who cannot join
- Pregnancy
- Patient under 18
- Unaccessible flap
Trial locations and contacts
4 sites in 1 country.
France4 sites
Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens
Amiens, 80000
Maxillo-Facial Surgery, Besancon Univestitary Hospital
Besançon, 25000
Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital
Besançon, 25000
Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire
Dijon, 21000
About this study
Official title: Evaluation of Free Tissue Flaps Viability With Capillary Glucose and Lactate Measurements Compared With Clinical Examination
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.
Read the detailed description
Free tissue flap reconstruction has become a reliable technique. Nevertheless, pedicle thrombosis is dreaded, and the earlier the diagnosis of such complications is made, the higher the surgical salvage rate is.
Clinical monitoring remains the most useful and used monitoring method, but makes late and unreliable diagnosis. Numerous studies are searching for ideal monitoring technics with regard to free flaps. Nowadays, the most efficient ones often deal with expensive and invasive technics. In this study, capillary lactataemia and glycaemia measurements are evaluated for pedicle impairments diagnosis.
Measurements of these 2 biological parameters seem to be a powerful screening test of pedicle impairments in microdialysis. But these parameters are measured in this case in interstitial tissues. Capillary measurements will probably provide different results, and needs to be evaluated.
For that purpose, surgical reconstructions with free tissue flap will be clinically monitored during five days, every hours for the first 24 hours, and every 4 hours for the next 4 days. Simultaneously, blind measurements of capillary lactataemia and glycaemia will be performed. Biological and clinical data will be systematically written in the corresponding table of the individual register together with the time the examination is done.
In this register, all complications and evolutions of the flaps will be recorded.
A posteriori, parallel between clinical and biological events will be studied. This multicenter prospective study will show first if capillary measurements of glucose and lactate permit to screen pedicle complications of free flaps. In case of efficacy of this technique, thresholds of glucose and lactate permitting such diagnoses will be calculated in order to define a sensitive screening test. Moreover, temporal differences between clinical and biological diagnoses of pedicle impairments will be studied.
- Conditions
- Postoperative Complications
- Being tested
- Lactate-meter: LactatePro (ARKRAY Inc)
- Keywords
- free tissue flaps, lactic acid, glucose, thrombosis, diagnostic test, Pedicle postoperative complications diagnosis
- Medical subject headings
- Postoperative Complications, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Capillary lactate is measured immediately after the end of the surgical procedure (Expected 1 to 5 hours after the end of arterial anastomosis).
Then, measurements are done every hours for the first 24 hours, and every 4 hours for the next 4 days.
In order to avoid bias, measurements are performed by caregivers after clinical examination, and they hadn't any information about expected results of lactate and glucose values.
Measured: 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
Capillary glucose is measured immediately after the end of the surgical procedure (Expected 1 to 5 hours after the end of arterial anastomosis).
Then, measurements are done every hours for the first 24 hours, and every 4 hours for the next 4 days.
In order to avoid bias, measurements are performed by caregivers after clinical examination, and they hadn't any information about expected results of lactate and glucose values.
Measured: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary lactate measurements and clinical examinations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Narcisse Zwetyenga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Narcisse Zwetyenga, Centre Hospitalier Universitaire Dijon
- Investigators
- Benoit Henault, MD, Study chair, Centre Hospitalier Universitaire DijonNarcisse Zwetyenga, PhD, Principal investigator, Centre Hospitalier Universitaire DijonJulien Pauchot, MD, Study chair, Centre Hospitalier Universitaire DijonRaphaël Sinna, MD, Study chair, Centre Hospitalier Universitaire, AmiensChristophe Meyer, PhD, Study chair, Centre Hospitalier Universitaire, Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445990
- Sponsor's protocol ID
- 2009-A01262-55
- Status last verified
- Oct 2011
- First submitted
- 30 Sep 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Free Tissue Flaps Viability With Capillary Glucose and Lactate Measurements Compared With Clinical Examination
- ClinicalTrials.gov ID
- NCT01445990
- Acronym / sponsor ID
- 2009-A01262-55
- Conditions
- Postoperative Complications
- Keywords
- free tissue flaps, lactic acid, glucose, thrombosis, diagnostic test, Pedicle postoperative complications diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Narcisse ZwetyengaUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire, Amiens
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Free tissue flap reconstruction has become a reliable technique. Nevertheless, pedicle thrombosis is dreaded, and the earlier the diagnosis of such complications is made, the higher the surgical salvage rate is.
Clinical monitoring remains the most useful and used monitoring method, but makes late and unreliable diagnosis. Numerous studies are searching for ideal monitoring technics with regard to free flaps. Nowadays, the most efficient ones often deal with expensive and invasive technics. In this study, capillary lactataemia and glycaemia measurements are evaluated for pedicle impairments diagnosis.
Measurements of these 2 biological parameters seem to be a powerful screening test of pedicle impairments in microdialysis. But these parameters are measured in this case in interstitial tissues. Capillary measurements will probably provide different results, and needs to be evaluated.
For that purpose, surgical reconstructions with free tissue flap will be clinically monitored during five days, every hours for the first 24 hours, and every 4 hours for the next 4 days. Simultaneously, blind measurements of capillary lactataemia and glycaemia will be performed. Biological and clinical data will be systematically written in the corresponding table of the individual register together with the time the examination is done.
In this register, all complications and evolutions of the flaps will be recorded.
A posteriori, parallel between clinical and biological events will be studied. This multicenter prospective study will show first if capillary measurements of glucose and lactate permit to screen pedicle complications of free flaps. In case of efficacy of this technique, thresholds of glucose and lactate permitting such diagnoses will be calculated in order to define a sensitive screening test. Moreover, temporal differences between clinical and biological diagnoses of pedicle impairments will be studied.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed patient
- Signed informed consent
- Free tissue flap reconstruction
- Accessible flap for measurements
Key exclusion criteria (3 listed)
- Pregnancy
- Patient under 18
- Unaccessible flap
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Clinical examination of the flap
Time frame: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose and lactate measurements.
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.
2 secondary outcomes
Capillary lactate measurements
Time frame: 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
Time frame: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary lactate measurements and clinical examinations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
Related trials for Postoperative Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Henault, MD study chair
Centre Hospitalier Universitaire Dijon
Narcisse Zwetyenga, PhD principal investigator
Centre Hospitalier Universitaire Dijon
Julien Pauchot, MD study chair
Centre Hospitalier Universitaire Dijon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactate-meter: LactatePro (ARKRAY Inc) in people with Postoperative Complications, run by Narcisse Zwetyenga at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical examination of the flap (time frame: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose and lactate measurements.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2011.