Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging in Burn Patients

NCT05037916 | Completed DMC

• 1 other identifier: L2019017 /NL66174.100.18
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Timely and accurate estimation of the surface area and depth of a burn injury is essential for determining an appropriate treatment modality. Inappropriate or inadequate treatment may result in complications and increased societal costs. Burn depth is determined by subjective assessing the characteristics of burn injury. Some objective methods are available (e.g., biopsy and histology, thermography and laser doppler imaging), but these are cumbersome. In assessing burn wounds, laser Doppler imaging (LDI) which has a good correlation with histology, is currently the most widely used and validated noninvasive measurement tool. In addition, it is the only technique that has been approved by the U.S. Food and Drug Administration. However, the use of LDI is accompanied by some disadvantages. The current commercial available LDI device is rather costly, cumbersome and has a poor spatial resolution. Another laser-based technique, laser speckle contrast imaging (LSCI), works with a similar principle and might become an alternative for LDI. LSCI has some advantages over LDI such as higher spatial resolution, much easier to position, no valuable time wasted on setting up the instrument, easy to take several images of burns that have a large surface area and/or much curvature, faster measurements, fraction of the time needed for getting a high-quality measurement, able to follow changes in the perfusion in real time. In contrast to the LDI, the LSCI has not been validated in terms of a diagnostic tool for stratifying the severity of a burn (based on LDI color coding). Consequently, we will compare the LSCI with LDI to improve burn care by providing cheaper, faster and higher resolution imaging technique.

Conditions

Laser Burn

Outcome Measures

Primary Outcomes (1)

• primary outcome

  o To validate the LSCI device (Perimed AB, Järfälla, Sweden) in burn patients.

  10 minutes

Secondary Outcomes (1)

• secondary outcome

  10 minutes

Interventions

laser speckle contrast imaging device OTHER

laser speckle contrast imaging device will be used for measurement of burn wound depth en to be compared to the golden standard the laser doppler imaging device

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• All consecutive adult patients with acute burn wounds, who are seen within 5 day post burn in the Burn Centre of the Maasstad hospital are eligible to enroll in the study.

You may qualify if:

• ≥ 16 years old
• Acute burn wounds admitted in the Burn Centre of the Maasstad hospital
• Assessment burn wounds with laser Doppler imager

You may not qualify if:

• Pregnant
• Unconscious patients

Sponsors & Collaborators

• Maasstad Hospital: lead

Study Sites (1)

Maastad hospital

Rotterdam, South Netherlands, 3079DZ, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: September 8, 2021
• Study Start: April 15, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: September 8, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)