Cost-effectiveness of Laser Doppler Imaging in Burn Care in the Netherlands
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 6
- Primary Endpoint
- Wound healing time
Study Overview
Brief 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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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%
Outcomes
Primary Outcomes
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
- The effect of LDI on total (medical and non medical) costs(From injury until 3 months post burn)
- The effect of LDI on patient outcomes: quality of life and scar quality(3 months post burn)
- The effect of LDI on diagnostic and therapeutic decisions(Until wound healing, circa 2-6 weeks)
- The cost-effectiveness of LDI compared to the standard diagnostic strategy(From injury until 3 months post burn)