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BurnsNCT01489540

Cost-effectiveness of Laser Doppler Imaging in Burn Care

A study testing laser Doppler imager (Moor) in people with Burns, run by Association of Dutch Burn Centres at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Accurate early burn depth assessment is important to determine the optimal treatment. The most applied method to asses burn depth is clinical assessment. This method is the least expensive, but not very accurate. Laser Doppler imaging (LDI) has been shown to accurately assess burn depth. Read more about this study

Who is it for?
Any age
Conditions the study is for
Burns
What is being tested?
laser Doppler imager (Moor)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesNetherlands
Study dates
Dec 2011to Mar 2013
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with acute burns of indeterminate depth (=intermediate depth, not obviously superficial or full thickness) at presentation
  • Outpatient treatment or admission in one of the three Dutch burn centres
  • Presentation within 5 days post burn

Who cannot join

  • A presence of both burns of indeterminate depth and full thickness at presentation
  • Patients with peri-orbital facial burns, in which the eyes are unable to shield
  • Patients or their next of kin if they are under aged or temporary incompetent who can not be expected to give informed consent e.g. because of cognitive dysfunction or poor Dutch proficiency.
  • Patients with a TBSA burned > 20%

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Red Cross Hospital

    Beverwijk, North Holland, 1940 EB

  • Martini Hospital

    Groningen, Provincie Groningen, 9700 RM

  • Maasstad Hospital

    Rotterdam, South Holland, 3079 DZ

Other trials in Netherlands

About this study

Official title: Cost-effectiveness of Laser Doppler Imaging in Burn Care in the Netherlands

Accurate early burn depth assessment is important to determine the optimal treatment. The most applied method to asses burn depth is clinical assessment. This method is the least expensive, but not very accurate. Laser Doppler imaging (LDI) has been shown to accurately assess burn depth. The clinical effects, the costs and cost-effectiveness of this device however, are unknown. The hypothesis is that an eary accurate diagnosis will lead to an earlier therapeutic decision: surgery or no surgery. Earlier excision and grafting probably leads to a decrease in wound healing time, in length of hospital stay and in costs.

Before the investigators decide to implement LDI in Dutch burn care a study of the clinical effects and cost-effectiveness of LDI is necessary. Therefore a multicenter randomized controlled trial will be conducted, including all patients with burns of indeterminate depth (burns that are not obviously superficial or full thickness) treated in the Dutch burn centres. In total 200 patients will be included in an 18 months period. The patients are randomly divided in two groups: 'new diagnostic strategy' versus 'current diagnostic strategy'. Burn depth will be diagnosed both by clinical assessment and laser Doppler imaging in all patients. The results of the LDI-scan will be provided to the treating clinician in the 'new diagnostic strategy' group only. Time to wound healing, diagnostic and therapeutic decisions, and costs are observed.

Conditions
Burns
Being tested
laser Doppler imager (Moor)
Keywords
Burn, Depth, Diagnosis, Laser Doppler Imaging
Medical subject headings
Burns, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laser Doppler imager (Moor)Device

    Also called Laser Doppler Imager, Moor Instruments, Moor LDI Burn Imager

    The laser Doppler imager measures the blood flow of the skin/burn

Study groups in NCT01489540
Study groupRoleWhat they receive
new diagnostic strategyActive comparatorCombination of laser Doppler imaging and clinical assessment of burn depth
Receives: Device: laser Doppler imager (Moor)
current diagnostic strategyNo interventionClinical assessment of burn depth

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound healing time

    Time to complete wound healing (>95 % reepithelialisation) and rate of wound healing (% reepithelialisation) at day 14 post burn will be assessed clinically (Bloemen et al., 2011)

    Measured: 14 days post burn

Secondary outcomes (4)

  1. The effect of LDI on patient outcomes: quality of life and scar quality

    Quality of life is measured with the EuroQol-5D in patient ≥ 5 years old (Bouillon et al., 2002) or the ItQol-47 in patients <5 years old (Raat et al., 2007):

    1. Baseline measurement within one month post burn
    2. Second measurement within 3 months post burn

    Scar quality is measured after 3 months:

    1. Scar elasticity with the Cutometer® Skin Elasticity Meter 575 (Draaijers et al., 2004)
    2. Vascularity and pigmentation with the Dermaspectometer (Draaijers et al., 2004)
    3. Self-reported scar quality: Patients Observer Scar Assessment Scale (van der Wal et al., 2011)

    Measured: 3 months post burn

  2. The effect of LDI on diagnostic and therapeutic decisions

    Effect of the introduction of the LDI will be assessed by comparing diagnostic decisions of burn clinicians, before and after the use of LDI.

    Possible diagnostic decisions are (Monstrey et al., 2011):

    • Superficial dermal burn, will heal (within 14 days)
    • Intermediate burn (possible will heal, or needs grafting)
    • Deep dermal or subdermal (full thickness) burn, needs grafting (will not heal within 21 days)

    The possible therapeutic decisions are:

    • Surgery
    • Postponement of decision
    • No surgery

    Measured: Until wound healing, circa 2-6 weeks

  3. The effect of LDI on total (medical and non medical) costs

    Costs from a societal perspective are calculated (following the Dutch guidelines from Oostenbrink et al., 2004):

    1. Costs during hospital stay
    2. Outpatient costs
    3. Non-hospital and non-medical costs

    Measured: From injury until 3 months post burn

  4. The cost-effectiveness of LDI compared to the standard diagnostic strategy

    In case of differences in patient outcome (wound healing time and scar quality) between both diagnostic strategies, cost-effectiveness will be calculated by dividing the difference in average costs by the difference in average time of wound healing or scar quality.

    In case of difference in quality of life between both diagnostic strategies, cost-utility will be calculated by dividing the difference in average costs by the difference in Quality Adjusted Life Years (QALY's).

    Measured: From injury until 3 months post burn

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionDec 2012
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01489540
Sponsor's protocol ID
2011-47
Status last verified
Dec 2011
First submitted
30 Nov 2011
Last updated
19 Sep 2013
Results posted
No
Data monitoring committee
No

Publications

  • Kim LH, Ward D, Lam L, Holland AJ. The impact of laser Doppler imaging on time to grafting decisions in pediatric burns. J Burn Care Res. 2010 Mar-Apr;31(2):328-32. doi: 10.1097/BCR.0b013e3181d0f572.

    PubMed 20182369

  • Monstrey S, Hoeksema H, Verbelen J, Pirayesh A, Blondeel P. Assessment of burn depth and burn wound healing potential. Burns. 2008 Sep;34(6):761-9. doi: 10.1016/j.burns.2008.01.009. Epub 2008 Jun 3.

    PubMed 18511202

  • Jeng JC, Bridgeman A, Shivnan L, Thornton PM, Alam H, Clarke TJ, Jablonski KA, Jordan MH. Laser Doppler imaging determines need for excision and grafting in advance of clinical judgment: a prospective blinded trial. Burns. 2003 Nov;29(7):665-70. doi: 10.1016/s0305-4179(03)00078-0.

    PubMed 14556723

  • Engrav LH, Heimbach DM, Reus JL, Harnar TJ, Marvin JA. Early excision and grafting vs. nonoperative treatment of burns of indeterminant depth: a randomized prospective study. J Trauma. 1983 Nov;23(11):1001-4. doi: 10.1097/00005373-198311000-00007.

    PubMed 6355500

  • Herndon DN, Barrow RE, Rutan RL, Rutan TC, Desai MH, Abston S. A comparison of conservative versus early excision. Therapies in severely burned patients. Ann Surg. 1989 May;209(5):547-52; discussion 552-3. doi: 10.1097/00000658-198905000-00006.

    PubMed 2650643

  • Bloemen MC, van Zuijlen PP, Middelkoop E. Reliability of subjective wound assessment. Burns. 2011 Jun;37(4):566-71. doi: 10.1016/j.burns.2011.02.004. Epub 2011 Mar 8.

    PubMed 21388743

  • Bouillon B, Kreder HJ, Eypasch E, Holbrook TL, Kreder HJ, Mayou R, Nast-Kolb D, Pirente N, Schelling G, Tiling T, Yates D; MI Consensus Group. Quality of life in patients with multiple injuries--basic issues, assessment, and recommendations. Restor Neurol Neurosci. 2002;20(3-4):125-34.

    PubMed 12454361

  • Raat H, Landgraf JM, Oostenbrink R, Moll HA, Essink-Bot ML. Reliability and validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) in a general population and respiratory disease sample. Qual Life Res. 2007 Apr;16(3):445-60. doi: 10.1007/s11136-006-9134-8. Epub 2006 Nov 17.

    PubMed 17111231

  • Draaijers LJ, Botman YA, Tempelman FR, Kreis RW, Middelkoop E, van Zuijlen PP. Skin elasticity meter or subjective evaluation in scars: a reliability assessment. Burns. 2004 Mar;30(2):109-14. doi: 10.1016/j.burns.2003.09.003.

    PubMed 15019116

  • Draaijers LJ, Tempelman FR, Botman YA, Kreis RW, Middelkoop E, van Zuijlen PP. Colour evaluation in scars: tristimulus colorimeter, narrow-band simple reflectance meter or subjective evaluation? Burns. 2004 Mar;30(2):103-7. doi: 10.1016/j.burns.2003.09.029.

    PubMed 15019115

  • van der Wal MB, Tuinebreijer WE, Bloemen MC, Verhaegen PD, Middelkoop E, van Zuijlen PP. Rasch analysis of the Patient and Observer Scar Assessment Scale (POSAS) in burn scars. Qual Life Res. 2012 Feb;21(1):13-23. doi: 10.1007/s11136-011-9924-5. Epub 2011 May 20.

    PubMed 21598065

  • Monstrey SM, Hoeksema H, Baker RD, Jeng J, Spence RS, Wilson D, Pape SA. Burn wound healing time assessed by laser Doppler imaging. Part 2: validation of a dedicated colour code for image interpretation. Burns. 2011 Mar;37(2):249-56. doi: 10.1016/j.burns.2010.08.013. Epub 2010 Nov 16.

    PubMed 21084164

  • Hop MJ, Stekelenburg CM, Hiddingh J, Kuipers HC, Middelkoop E, Nieuwenhuis MK, Polinder S, van Baar ME; LDI Study Group. Cost-Effectiveness of Laser Doppler Imaging in Burn Care in The Netherlands: A Randomized Controlled Trial. Plast Reconstr Surg. 2016 Jan;137(1):166e-176e. doi: 10.1097/PRS.0000000000001900.

    PubMed 26710049

  • Hop MJ, Hiddingh J, Stekelenburg C, Kuipers HC, Middelkoop E, Nieuwenhuis MK, Polinder S, van Baar ME; LDI study group. Cost-effectiveness of laser Doppler imaging in burn care in the Netherlands. BMC Surg. 2013 Feb 1;13:2. doi: 10.1186/1471-2482-13-2.

    PubMed 23369360

Questions about this trial

What is this clinical trial studying?

A study testing laser Doppler imager (Moor) in people with Burns, run by Association of Dutch Burn Centres at 3 sites in Netherlands.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound healing time (time frame: 14 days post burn). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01489540, which also lists 14 linked publications.

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 19 Sep 2013.

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