Cost-effectiveness of Laser Doppler Imaging in Burn Care

Association of Dutch Burn Centres

Status

Completed

Conditions

Burns

Treatments

Device: laser Doppler imager (Moor)

Study type

Interventional

Funder types

Other

Identifiers

NCT01489540

2011-47

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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%