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Completed

NCT Number: NCT01489540

Cost-effectiveness of Laser Doppler Imaging in Burn Care

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.

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Key information

Conditions

Burns Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Red Cross Hospital, Beverwijk, North Holland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

laser Doppler imager (Moor)

Device

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

Other names: Laser Doppler Imager, Moor Instruments, Moor LDI Burn Imager

Primary outcomes

  1. Wound healing time

    Time frame: 14 days post burn

    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)

Secondary outcomes

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

    Time frame: 3 months post burn

    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):

    • Baseline measurement within one month post burn
    • Second measurement within 3 months post burn

    Scar quality is measured after 3 months:

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

  2. The effect of LDI on diagnostic and therapeutic decisions

    Time frame: Until wound healing, circa 2-6 weeks

    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

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

    Time frame: From injury until 3 months post burn

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

    • Costs during hospital stay
    • Outpatient costs
    • Non-hospital and non-medical costs

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

    Time frame: From injury until 3 months post burn

    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).

Sponsors and collaborators

Lead sponsor

Association of Dutch Burn Centres

Other

Collaborators

  • Dutch Burns Foundation
  • Stichting Nuts Ohra

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Dec 9, 2011
Registry last updated
Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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