Imaging of Adult Burn Injuries

Thermography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02074787
• Other study ID #: C&W13/090
• Secondary ID: 14/EE/0048141406
• Status: Not yet recruiting
• Phase: N/A
• First received: February 27, 2014
• Last updated: February 27, 2014
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: February 2014
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: Jonathan M Collier, MA MFDS FRCS(OMFS) PHD
• Phone: 07957 332966
• Email: jcollier[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: NHS Research Authority
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• children patients not consenting

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Laser Doppler Blood Flow
• Spectrophotometric Intracutaneous Analysis
• Thermography

Intervention

Device:
• Thermography
Standard thermographic images
• Laser Doppler
standard laser doppler analysis
• Spectrophotometric Intracutaneous analysis
standard SIA scope imaging

Locations

Country	Name	City	State
United Kingdom	Chelsea & Westminster NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust	Royal College of Surgeons of England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	95% healing	The time to 95% epithelial healing of adult burn injuries as assessed by experienced burns clinicians	within 4 weeks of presentation	No