Cost-effectiveness of Laser Doppler Imaging in Burn Care

This study has been completed.
Sponsor:
Collaborators:
Dutch Burns Foundation
Stichting Nuts Ohra
Information provided by (Responsible Party):
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT01489540
First received: November 30, 2011
Last updated: September 18, 2013
Last verified: December 2011

November 30, 2011
September 18, 2013
December 2011
December 2012   (final data collection date for primary outcome measure)
Wound healing time [ Time Frame: 14 days post burn ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01489540 on ClinicalTrials.gov Archive Site
  • The effect of LDI on patient outcomes: quality of life and scar quality [ Time Frame: 3 months post burn ] [ Designated as safety issue: No ]

    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)
  • The effect of LDI on diagnostic and therapeutic decisions [ Time Frame: Until wound healing, circa 2-6 weeks ] [ Designated as safety issue: No ]

    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
  • The effect of LDI on total (medical and non medical) costs [ Time Frame: From injury until 3 months post burn ] [ Designated as safety issue: No ]

    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
  • The cost-effectiveness of LDI compared to the standard diagnostic strategy [ Time Frame: From injury until 3 months post burn ] [ Designated as safety issue: No ]

    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).

Same as current
Not Provided
Not Provided
 
Cost-effectiveness of Laser Doppler Imaging in Burn Care
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Burns
Device: laser Doppler imager (Moor)
The laser Doppler imager measures the blood flow of the skin/burn
Other Names:
  • Laser Doppler Imager, Moor Instruments
  • Moor LDI Burn Imager
  • Active Comparator: new diagnostic strategy
    Combination of laser Doppler imaging and clinical assessment of burn depth
    Intervention: Device: laser Doppler imager (Moor)
  • No Intervention: current diagnostic strategy
    Clinical assessment of burn depth

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

  • 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

Exclusion criteria

  • 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%
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01489540
2011-47
No
Association of Dutch Burn Centres
Association of Dutch Burn Centres
  • Dutch Burns Foundation
  • Stichting Nuts Ohra
Study Chair: Margriet E Baar, PhD Associaton of Dutch Burns Centres
Association of Dutch Burn Centres
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP