- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05037916
Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging in Burn Patients (COLA-B)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After receiving adequate information and when informed consent is signed, patients are included. All patients receive usual care. Within 2-5 days post burn the LSCI and LDI are performed. Ideally, LDI is performed after 2 days, scanning up to 5 days is permitted when patients present later post burn or due to logistic reasons. The wounds are scanned by a trained research physician or nurse, during regular wound care.
8.4 Population base: Measurements of microcirculation with laser-based technique will be initiated upon the ethical consent is approved. Fifty burn patients will be included in the study. All patients will be asked for the existence of any comorbid disease. Once the patient meets the inclusion criteria, he will be eligible for the study.
LSCI and LDI devices will alternately be used to record blood flux. Burn wound including the healthy area 5 cm wider than the borders will be scanned by LDI and LSCI. After completing the data collection, all images will be compared to test the linearity between arbitrary units of LDI and LSCI. Based on the measured blood flux, a color image will be created, based on a color map created in a study on volunteers. Blood flux is calculated by the dedicated software.
Names of the patients will be coded with numbers. Only the main investigator will be aware of who corresponds to which number. Results of Perimed (LSCI) and Moore Devices (LDI) will be analyzed with the software PIMsoft 1.5 (Perimed AB, Järfälla, Sweden), MoorLDI2-BI Burn's Software Version 4.0, respectively. Two investigators will perform the analysis. If one investigator will make the analysis, the other will check the results, as well. Stored data will be extracted and stored coded in the castor study management system en electronic data capture system.
Assessment of microcirculation with the Perimed LSCI Pericam PSI System (Perimed AB, Järfälla, Sweden) Laser Speckle Contrast Imager is used to measure skin perfusion. The system uses a divergent laser beam with a wavelength of 785 nm. Perfusion images are acquired by averaging data from 21 images taken in rapid succession (acquisition time 1 seconds), over 1-minute intervals. A flexible working distance from 10 to 40 cm allows measurement areas up to 24 x 24 cm. Tissue blood perfusion is visualized in real time with a resolution of up to 100 µm/pixel. The system is calibrated according to the manufacturer recommendations. Perfusion images will be further analyzed by calculating mean perfusion levels in regions of interest using PIMsoft 1.5 (Perimed AB, Järfälla, Sweden).
Operating procedures:
- Switch on the computer and any peripherals
- Switch on the Perimed instrument to be used via the switch on the rear panel
- Allow the instrument at least 5 minutes for warm-up
- Start the PIMSoft software on computer
- Make sure that you allowed the subject at least 20 minutes to rest and acclimatize before the measurement, make sure the subject is in a comfortable position.
- Position the instrument head within the recommended measurement distance from the tissue (10-40 cm)
- The head should be parallel, and the laser beam perpendicular to the tissue being measured
- Set the size of the measurement area by entering the desired width and height in the corresponding text boxes. Select a point density (resolution).
- Click on the start button
- After recording the image and/or video click on the stop button and finalize the recording
- Recorded document is already saved to the computer
Assessment of microcirculation with the Moor LDI
MoorLDI2-BI System (Moor Instruments Ltd., Axminster, Devon, UK) is used to measure skin perfusion. The system uses a divergent laser beam with a wavelength of 633 nm. A flexible working distance from 30 to 100 cm allows measurement areas up to 50 x 50 cm. Scan times are ranging from 40 seconds up to 2 minutes. The scan speed is approximately 4ms/pixel. Tissue blood perfusion is visualized in real time with a maximum image resolution of 256x256 pixels. The system is calibrated according to the manufacturer recommendations. Perfusion images will be further analyzed by calculating mean perfusion levels in regions of interest using MoorLDI2-BI Burn's Software Version 4.0.
Operating procedures:
- It is common practice to perform moorLDI2-BI scans after dressings have been removed during routine dressing change. This avoids extra patient discomfort.
- Remove dressings (during routine wound management) and any cream (e.g., silver sulphadiazine) to a light smear or better.
- Position the patient with due regard to maintenance of a sterile environment for the wound. The wound should be held in a comfortable position so that it can be held reasonably still for the duration of the moorLDI2-BI scan.
- The patient should breathe normally during the scan and should avoid coughing or holding breath.
- When scanning the face and/or upper body areas, the eyes must be covered. If the patient is unable to wear eye protection, the face must not be scanned.
- Ensure that the room or space to be used for scanning has the correct laser warning labels and screening
- Ensure clean or sterilized eye protection is on hand for patient and staff if required.
- Angle the scan head downwards prior to turning on the moorLDI2-BI.
- Turn on the moorLDI2-BI.
- Enter Patient Information; use the Comment box for details of sickness, medication or any other factors which may influence peripheral blood flow.
- Plan to avoid scanning under direct sunlight, theatre lights or another bright lighting.
- Plan the scan head positions for all burn wounds. Consider scan directions that will avoid direct reflection of the moorLDI2-BI laser back into the scan head from moist wound surfaces.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
South Netherlands
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Rotterdam, South Netherlands, Netherlands, 3079DZ
- Maastad hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 16 years old
- Acute burn wounds admitted in the Burn Centre of the Maasstad hospital
- Assessment burn wounds with laser Doppler imager
Exclusion Criteria:
- Pregnant
- Unconscious patients
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary outcome
Time Frame: 10 minutes
|
o To validate the LSCI device (Perimed AB, Järfälla, Sweden) in burn patients.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
secondary outcome
Time Frame: 10 minutes
|
o To validate a color code, comparing LDI (moorLDI2-Burn Imager™ (Moor Instruments, Axminster, United Kingdom) and LSCI in burn patients
|
10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L2019017 /NL66174.100.18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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