ThermographyNCT02074787
Imaging of Adult Burn Injuries
An observational study of Thermography and Laser Doppler Blood Flow, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Thermography, Laser Doppler Blood Flow, Spectrophotometric Intracutaneous Analysis
- What is being tested?
- Thermography, Laser Doppler and Spectrophotometric Intracutaneous analysis
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Sep 2014
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- adults burn injury within 72 hours of presentation able to undergo all three imaging modalities
Who cannot join
- children patients not consenting
Trial locations and contacts
1 site in 1 country.
isobel Jones, MA FRCS(Plast) contact
United Kingdom1 site
Chelsea & Westminster NHS Foundation Trust
London, London, SW10 9NS
donna mclean, donna.mclean@chelwest.nhs.uk
Alexandra Burke-Smith, BSc
About this study
Official title: 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.
Read the 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.
- Being tested
- Thermography, Laser Doppler, Spectrophotometric Intracutaneous analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermographyDevice
Also called FLIR E50mx
Standard thermographic images
Laser DopplerDevice
Also called Moor systems laser doppler blood flow analysis
standard laser doppler analysis
Spectrophotometric Intracutaneous analysisDevice
Also called SIA scope
standard SIA scope imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Thermography; Device: Laser Doppler; Device: Spectrophotometric Intracutaneous analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
95% healing
The time to 95% epithelial healing of adult burn injuries as assessed by experienced burns clinicians
Measured: within 4 weeks of presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThermographyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons of England
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074787
- Sponsor's protocol ID
- C&W13/090
- Other IDs
- 14/EE/0048, 141406
- Status last verified
- Feb 2014
- First submitted
- 27 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Three Non-invasive Imaging Modalities (Thermography, Laser Doppler and SIAscope) for the Assessment of Adult Burns Injuries
- ClinicalTrials.gov ID
- NCT02074787
- Acronym / sponsor ID
- C&W13/090
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal College of Surgeons of England
- Study start
- Mar 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 28 Feb 2014 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult burn injuries | – | Device: Thermography, Device: Laser Doppler, Device: Spectrophotometric Intracutaneous analysisAdult 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- adults burn injury within 72 hours of presentation able to undergo all three imaging modalities
Key exclusion criteria (1 listed)
- children patients not consenting
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 |
|---|---|---|
| ThermographyAlso: FLIR E50mxStandard thermographic images | Device | Adult burn injuries |
| Laser DopplerAlso: Moor systems laser doppler blood flow analysisstandard laser doppler analysis | Device | Adult burn injuries |
| Spectrophotometric Intracutaneous analysisAlso: SIA scopestandard SIA scope imaging | Device | Adult burn injuries |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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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.
isobel Jones, MA FRCS(Plast) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thermography and Laser Doppler Blood Flow, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan M Collier, MA MFDS FRCS(OMFS) PHD (07957 332966, jcollier@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
95% healing (time frame: within 4 weeks of presentation). 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 28 Feb 2014.