Cost-effectiveness of Laser Doppler Imaging in Burn Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Burns

Intervention / Treatment
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* Device: laser Doppler imager (Moor)


Participation Criteria
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Eligibility Criteria
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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%
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: new diagnostic strategy<br>Combination of laser Doppler imaging and clinical assessment of burn depth | Device: laser Doppler imager (Moor)<br>* The laser Doppler imager measures the blood flow of the skin/burn<br>* Other names: Moor LDI Burn Imager;|
| No Intervention: current diagnostic strategy<br>Clinical assessment of burn depth | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 14 days post burn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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): 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) | 3 months post burn | 
| 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 | Until wound healing, circa 2-6 weeks | 
| 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): Costs during hospital stay Outpatient costs Non-hospital and non-medical costs | From injury until 3 months post burn | 
| 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). | From injury until 3 months post burn | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn, Depth, Diagnosis, Laser Doppler Imaging