Cost-effectiveness of Laser Doppler Imaging in Burn Care

This study has been completed.
Sponsor:
Collaborators:
Dutch Burns Foundation
Stichting Nuts Ohra
Information provided by (Responsible Party):
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT01489540
First received: November 30, 2011
Last updated: September 18, 2013
Last verified: December 2011
  Purpose

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.


Condition Intervention
Burns
Device: laser Doppler imager (Moor)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cost-effectiveness of Laser Doppler Imaging in Burn Care in the Netherlands

Resource links provided by NLM:


Further study details as provided by Association of Dutch Burn Centres:

Primary Outcome Measures:
  • Wound healing time [ Time Frame: 14 days post burn ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • The effect of LDI on patient outcomes: quality of life and scar quality [ Time Frame: 3 months post burn ] [ Designated as safety issue: No ]

    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)

  • The effect of LDI on diagnostic and therapeutic decisions [ Time Frame: Until wound healing, circa 2-6 weeks ] [ Designated as safety issue: No ]

    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

  • The effect of LDI on total (medical and non medical) costs [ Time Frame: From injury until 3 months post burn ] [ Designated as safety issue: No ]

    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

  • The cost-effectiveness of LDI compared to the standard diagnostic strategy [ Time Frame: From injury until 3 months post burn ] [ Designated as safety issue: No ]

    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).



Estimated Enrollment: 200
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489540

Locations
Netherlands
Red Cross Hospital
Beverwijk, Noord-Holland, Netherlands, 1940 EB
Maasstad Hospital
Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
Martini Hospital
Groningen, Netherlands, 9700 RM
Sponsors and Collaborators
Association of Dutch Burn Centres
Dutch Burns Foundation
Stichting Nuts Ohra
Investigators
Study Chair: Margriet E Baar, PhD Associaton of Dutch Burns Centres
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT01489540     History of Changes
Other Study ID Numbers: 2011-47
Study First Received: November 30, 2011
Last Updated: September 18, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Association of Dutch Burn Centres:
Burn
Depth
Diagnosis
Laser Doppler Imaging

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014