Cost-effectiveness of Laser Doppler Imaging in Burn Care

September 18, 2013 updated by: Association of Dutch Burn Centres

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RM
        • Martini Hospital
    • Noord-Holland
      • Beverwijk, Noord-Holland, Netherlands, 1940 EB
        • Red Cross Hospital
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
        • Maasstad Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: new diagnostic strategy
Combination of laser Doppler imaging and clinical assessment of burn depth
Device: laser Doppler imager (Moor)
The laser Doppler imager measures the blood flow of the skin/burn
Other Names:
  • Laser Doppler Imager, Moor Instruments
  • Moor LDI Burn Imager
No Intervention: current diagnostic strategy
Clinical assessment of burn depth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
14 days post burn

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of LDI on patient outcomes: quality of life and scar quality
Time Frame: 3 months post burn

Quality of life is measured with the EuroQol-5D in patient ≥ 5 years old (Bouillon et al., 2002) or the ItQol-47 in patients <5 years old (Raat et al., 2007):

  1. Baseline measurement within one month post burn
  2. Second measurement within 3 months post burn

Scar quality is measured after 3 months:

  1. Scar elasticity with the Cutometer® Skin Elasticity Meter 575 (Draaijers et al., 2004)
  2. Vascularity and pigmentation with the Dermaspectometer (Draaijers et al., 2004)
  3. Self-reported scar quality: Patients Observer Scar Assessment Scale (van der Wal et al., 2011)
3 months post burn
The effect of LDI on diagnostic and therapeutic decisions
Time Frame: Until wound healing, circa 2-6 weeks

Effect of the introduction of the LDI will be assessed by comparing diagnostic decisions of burn clinicians, before and after the use of LDI.

Possible diagnostic decisions are (Monstrey et al., 2011):

  • Superficial dermal burn, will heal (within 14 days)
  • Intermediate burn (possible will heal, or needs grafting)
  • Deep dermal or subdermal (full thickness) burn, needs grafting (will not heal within 21 days)

The possible therapeutic decisions are:

  • Surgery
  • Postponement of decision
  • No surgery
Until wound healing, circa 2-6 weeks
The effect of LDI on total (medical and non medical) costs
Time Frame: From injury until 3 months post burn

Costs from a societal perspective are calculated (following the Dutch guidelines from Oostenbrink et al., 2004):

  1. Costs during hospital stay
  2. Outpatient costs
  3. Non-hospital and non-medical costs
From injury until 3 months post burn
The cost-effectiveness of LDI compared to the standard diagnostic strategy
Time Frame: From injury until 3 months post burn

In case of differences in patient outcome (wound healing time and scar quality) between both diagnostic strategies, cost-effectiveness will be calculated by dividing the difference in average costs by the difference in average time of wound healing or scar quality.

In case of difference in quality of life between both diagnostic strategies, cost-utility will be calculated by dividing the difference in average costs by the difference in Quality Adjusted Life Years (QALY's).
From injury until 3 months post burn

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association of Dutch Burn Centres

Collaborators

Stichting Nuts Ohra
Dutch Burns Foundation

Investigators

  • Study Chair: Margriet E Baar, PhD, Associaton of Dutch Burns Centres

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

December 8, 2011

First Posted (Estimate)

December 9, 2011

Study Record Updates

Last Update Posted (Estimate)

September 19, 2013

Last Update Submitted That Met QC Criteria

September 18, 2013

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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