Clinical trial NCT01489540: Cost-effectiveness of Laser Doppler Imaging in Burn Care
Official title: Cost-effectiveness of Laser Doppler Imaging in Burn Care in the Netherlands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Burn
Depth
Diagnosis
Laser Doppler Imaging
Lead sponsor: Association of Dutch Burn Centres
Sponsor class: OTHER
Collaborators: name: Dutch Burns Foundation
name: Stichting Nuts Ohra
First posted: 2011-12-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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%

Primary outcomes:
measure: Wound healing time
timeFrame: 14 days post burn
Secondary outcomes:
measure: The effect of LDI on patient outcomes: quality of life and scar quality
timeFrame: 3 months post burn
measure: The effect of LDI on diagnostic and therapeutic decisions
timeFrame: Until wound healing, circa 2-6 weeks
measure: The effect of LDI on total (medical and non medical) costs
timeFrame: From injury until 3 months post burn
measure: The cost-effectiveness of LDI compared to the standard diagnostic strategy
timeFrame: From injury until 3 months post burn
Other outcomes:
Locations:
city: Beverwijk
country: Netherlands
facility: Red Cross Hospital
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Martini Hospital
Study officials:
affiliation: Associaton of Dutch Burns Centres
name: Margriet E Baar, PhD
role: STUDY_CHAIR
References:
citation: Kim LH, Ward D, Lam L, Holland AJ. The impact of laser Doppler imaging on time to grafting decisions in pediatric burns. J Burn Care Res. 2010 Mar-Apr;31(2):328-32. doi: 10.1097/BCR.0b013e3181d0f572.
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citation: van der Wal MB, Tuinebreijer WE, Bloemen MC, Verhaegen PD, Middelkoop E, van Zuijlen PP. Rasch analysis of the Patient and Observer Scar Assessment Scale (POSAS) in burn scars. Qual Life Res. 2012 Feb;21(1):13-23. doi: 10.1007/s11136-011-9924-5. Epub 2011 May 20.
citation: Monstrey SM, Hoeksema H, Baker RD, Jeng J, Spence RS, Wilson D, Pape SA. Burn wound healing time assessed by laser Doppler imaging. Part 2: validation of a dedicated colour code for image interpretation. Burns. 2011 Mar;37(2):249-56. doi: 10.1016/j.burns.2010.08.013. Epub 2010 Nov 16.
citation: Hop MJ, Stekelenburg CM, Hiddingh J, Kuipers HC, Middelkoop E, Nieuwenhuis MK, Polinder S, van Baar ME; LDI Study Group. Cost-Effectiveness of Laser Doppler Imaging in Burn Care in The Netherlands: A Randomized Controlled Trial. Plast Reconstr Surg. 2016 Jan;137(1):166e-176e. doi: 10.1097/PRS.0000000000001900.
citation: Hop MJ, Hiddingh J, Stekelenburg C, Kuipers HC, Middelkoop E, Nieuwenhuis MK, Polinder S, van Baar ME; LDI study group. Cost-effectiveness of laser Doppler imaging in burn care in the Netherlands. BMC Surg. 2013 Feb 1;13:2. doi: 10.1186/1471-2482-13-2.