Imaging of Adult Burn Injuries

February 27, 2014 updated by: Chelsea and Westminster NHS Foundation Trust

A Comparison of Three Non-invasive Imaging Modalities (Thermography, Laser Doppler and SIAscope) for the Assessment of Adult Burns Injuries

Burn injuries are a common presentation to A&E in the UK (175,000 per year) of whom 13,000 require hospital admission. Treatment of a single burn can cost more than £63,000, and is ultimately dependent on the depth. Most burns are assessed by experienced clinicians within a few days of injury. Accurate evaluation of burn depth can be very difficult with the naked eye. Inaccuracy can lead to longer hospital stays, worse scarring and greater financial costs for the NHS. Where the burn depth (and the degree of damage to the underlying blood supply of the skin) is not clear by visual inspection, adjuncts may be used to aid clinical decision-making. Currently, the "gold standard" method of assessing skin blood flow in order to help burn specialists in their assessment of burn depth is Laser Doppler Imaging (LDI). However, LDI machines can be very large, slow to collect the images, and a single imaging unit costs roughly £50,000. Consequently their use is restricted to the assessment of small burns in compliant patients treated in specialist units. Thermal imaging (thermography) has evolved rapidly as a useful diagnostic tool in many medical disciplines. Previous studies have shown that there are significant changes in skin physiology (such as temperature and pigmentation) depending on the depth of the burn. Portable, high-resolution thermal cameras are now affordable, easy to use and can provide numerical results in under a second. Similarly, measurement of skin pigment levels can be achieved using portable devices such as the Spectrophotometric Intracutaneous analysis scope (SIAscope). The aim of this study is to determine if alternative measures such as thermography or SIAscope can be as useful in the assessment of adult burns as LDI currently is. If this study demonstrates this then these results will inform further studies that would investigate these alternative imaging methods as a diagnostic and prognostic tool in the management of burns not only in adults but also in children presenting to non-specialised units such as A&E.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Adult acute burn injuries are currently "read" by experienced clinicians at 2-3 days post injury in order to determine the necessary treatment and likely clinical outcome. Adjuncts to this process aim to inform the clinician of structural damage to the sub dermal vasculature. The current gold standard investigation is laser doppler imaging (LDI) of dermal blood flow. However, due to time and resource constraints, this technique is often only applied to dermal burns of indeterminate thickness. Thermography and the SIAscope potential offer quicker, quantitative analysis with equipment currently in routine medical use in other clinical disciplines.

To validate its use against the current gold standard (LDI)burns of variable thicknesses will need to be assessed and compared with clinical outcome. Consequently, in this study, patients with superficial burns that would not usually require LDI will be included for comparison. All patients will be reassured that thermography, the SIAscope and LDI are non-invasive, non-harmful, quick and will not affect their burn management in any way. Images will be labelled by an anonymised study number and stored in on secure hospital servers according to the Trust's information governance policy.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jonathan M Collier, MA MFDS FRCS(OMFS) PHD
  • Phone Number: 07957 332966
  • Email: jcollier@nhs.net

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with burns injuries attending the regional burns unit at Chelsea & Westminster hospital between 48 and 72 hours post burn will be invited to take part in the study at the time of presentation to the unit.

Description

Inclusion Criteria:

  • adults burn injury within 72 hours of presentation able to undergo all three imaging modalities

Exclusion Criteria:

  • children patients not consenting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult burn injuries
Adult patients with burns injuries attending the regional burns unit at Chelsea & Westminster hospital between 48 and 72 hours post burn will be invited to take part in the study at the time of presentation to the unit.
Device: Thermography
Standard thermographic images
Other Names:
  • FLIR E50mx
Device: Laser Doppler
standard laser doppler analysis
Other Names:
  • Moor systems laser doppler blood flow analysis
Device: Spectrophotometric Intracutaneous analysis
standard SIA scope imaging
Other Names:
  • SIA scope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
95% healing
Time Frame: within 4 weeks of presentation
The time to 95% epithelial healing of adult burn injuries as assessed by experienced burns clinicians
within 4 weeks of presentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chelsea and Westminster NHS Foundation Trust

Collaborators

Royal College of Surgeons of England

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

February 28, 2014

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C&W13/090
  • 14/EE/0048 (Other Identifier: Regional Ethics Committee (UK))
  • 141406 (Other Identifier: IRAS project ID)

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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