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Objectives: In patients with burns an early accurate diagnosis of burn depth is essential to determine optimal treatment. The combination of Laser Doppler imaging (LDI) and clinical assessment leads to an accurate estimate of burn depth. However, the actual effects of the introduction of LDI on therapeutic decisions, clinical outcomes and costs are unknown. The aim of our study was to analyse the effectiveness and cost-effectiveness of LDI in burn care. The effects of LDI on decision-making, clinical outcomes, costs, and cost-effectiveness were assessed. MethOds: A randomised controlled trial was conducted in all three Dutch burn centres, including subsequent patients with burns of indeterminate depth. In the standard care (SC) group, burn depth and treatment choices were based on clinical assessment only, in the other group (LDI) clinical assessment and LDI results were combined. Primary outcome was the effect of the introduction of LDI on wound healing time. The economic evaluation was performed from a societal perspective with a bottom up approach, following the micro-costing method. Results: Mean time to wound healing from randomisation was 14.3 days in the LDI group and 15.5 days in the SC group (p= 0.258). In the subgroup of clinical patients requiring surgery earlier decision for surgery and a shorter wound healing time were observed in the LDI group (16.0 versus 19.9 days, p= 0.029). Mean total costs per patient were € 18 549 versus € 18 896 (p= 0.837). cOnclusiOns: LDI proved to provide guidance for therapeutic decisions with a significantly shorter wound healing time in the subgroup of clinical patients requiring surgery. When time to surgery can be reduced by 2.4 days, similar to the time to decision for surgery in our study, cost savings of € 794 per scanned patient can be achieved.

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BackgroundEarly accurate assessment of burn depth is important to determine the optimal treatment of burns. The method most used to determine burn depth is clinical assessment, which is the least expensive, but not the most accurate.Laser Doppler imaging (LDI) is a technique with which a more accurate (>95%) estimate of burn depth can be made by measuring the dermal perfusion. The actual effect on therapeutic decisions, clinical outcomes and the costs of the introduction of this device, however, are unknown. Before we decide to implement LDI in Dutch burn care, a study on the effectiveness and cost-effectiveness of LDI is necessary.Methods/designA multicenter randomised controlled trial will be conducted in the Dutch burn centres: Beverwijk, Groningen and Rotterdam. All patients treated as outpatient or admitted to a burn centre within 5 days post burn, with burns of indeterminate depth (burns not obviously superficial or full thickness) and a total body surface area burned of ≤ 20% are eligible. A total of 200 patients will be included. Burn depth will be diagnosed by both clinical assessment and laser Doppler imaging between 2–5 days post burn in all patients. Subsequently, patients are randomly divided in two groups: ‘new diagnostic strategy’ versus ‘current diagnostic strategy’. The results of the LDI-scan will only be provided to the treating clinician in the ‘new diagnostic strategy’ group. The main endpoint is the effect of LDI on wound healing time.In addition we measure: a) the effect of LDI on other patient outcomes (quality of life, scar quality), b) the effect of LDI on diagnostic and therapeutic decisions, and c) the effect of LDI on total (medical and non-medical) costs and cost-effectiveness.DiscussionThis trial will contribute to our current knowledge on the use of LDI in burn care and will provide evidence on its cost-effectiveness.Trial registrationNCT01489540

Therapeutic, I.