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CompletedNCT01489540

Cost-effectiveness of Laser Doppler Imaging in Burn Care

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Association of Dutch Burn Centres · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICElaser Doppler imager (Moor)The laser Doppler imager measures the blood flow of the skin/burn

Timeline

Start date
2011-12-01
Primary completion
2012-12-01
Completion
2013-03-01
First posted
2011-12-09
Last updated
2013-09-19

Locations

3 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01489540. Inclusion in this directory is not an endorsement.

Cost-effectiveness of Laser Doppler Imaging in Burn Care (NCT01489540) · Clinical Trials Directory