CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 target
Drug / intervention
laser Doppler imager (Moor)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01489540
NCT01489540N/ACompleted

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

Association of Dutch Burn Centres·interventional·Posted Dec 9, 2011·Updated Sep 19, 2013

In Brief

A clinical study evaluating laser Doppler imager (Moor) for Burns. Completed, enrolled 200 participants across 3 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns
CountriesNetherlands

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2011
Enrollment StartDec 1, 2011
Primary CompletionDec 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.6 years ago

Interventions

laser Doppler imager (Moor)device

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