NCT02074787

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

February 27, 2014

Last Update Submit

February 27, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 95% healing

    The time to 95% epithelial healing of adult burn injuries as assessed by experienced burns clinicians

    within 4 weeks of presentation

Study Arms (1)

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: ThermographyDevice: Laser DopplerDevice: Spectrophotometric Intracutaneous analysis

Interventions

Standard thermographic images

Also known as: FLIR E50mx
Adult burn injuries

standard laser doppler analysis

Also known as: Moor systems laser doppler blood flow analysis
Adult burn injuries

standard SIA scope imaging

Also known as: SIA scope
Adult burn injuries

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • children patients not consenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea & Westminster NHS Foundation Trust

London, London, SW10 9NS, United Kingdom

Location

MeSH Terms

Interventions

ThermographyLaser-Doppler Flowmetry

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisThermometryInvestigative TechniquesDiagnostic Techniques, CardiovascularRheology

Central Study Contacts

Jonathan M Collier, MA MFDS FRCS(OMFS) PHD

CONTACT

isobel Jones, MA FRCS(Plast)

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

February 28, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2014

Study Completion

September 1, 2014

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations