- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01489540
Cost-effectiveness of Laser Doppler Imaging in Burn Care
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
The laser Doppler imager measures the blood flow of the skin/burn
Other Names:
|
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):
Scar quality is measured after 3 months:
|
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):
The possible therapeutic decisions are:
|
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):
|
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
Investigators
- Study Chair: Margriet E Baar, PhD, Associaton of Dutch Burns Centres
Publications and helpful links
General Publications
- Draaijers LJ, Botman YA, Tempelman FR, Kreis RW, Middelkoop E, van Zuijlen PP. Skin elasticity meter or subjective evaluation in scars: a reliability assessment. Burns. 2004 Mar;30(2):109-14. doi: 10.1016/j.burns.2003.09.003.
- Monstrey S, Hoeksema H, Verbelen J, Pirayesh A, Blondeel P. Assessment of burn depth and burn wound healing potential. Burns. 2008 Sep;34(6):761-9. doi: 10.1016/j.burns.2008.01.009. Epub 2008 Jun 3.
- 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.
- 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.
- Jeng JC, Bridgeman A, Shivnan L, Thornton PM, Alam H, Clarke TJ, Jablonski KA, Jordan MH. Laser Doppler imaging determines need for excision and grafting in advance of clinical judgment: a prospective blinded trial. Burns. 2003 Nov;29(7):665-70. doi: 10.1016/s0305-4179(03)00078-0.
- Engrav LH, Heimbach DM, Reus JL, Harnar TJ, Marvin JA. Early excision and grafting vs. nonoperative treatment of burns of indeterminant depth: a randomized prospective study. J Trauma. 1983 Nov;23(11):1001-4. doi: 10.1097/00005373-198311000-00007.
- Herndon DN, Barrow RE, Rutan RL, Rutan TC, Desai MH, Abston S. A comparison of conservative versus early excision. Therapies in severely burned patients. Ann Surg. 1989 May;209(5):547-52; discussion 552-3. doi: 10.1097/00000658-198905000-00006.
- Bloemen MC, van Zuijlen PP, Middelkoop E. Reliability of subjective wound assessment. Burns. 2011 Jun;37(4):566-71. doi: 10.1016/j.burns.2011.02.004. Epub 2011 Mar 8.
- Bouillon B, Kreder HJ, Eypasch E, Holbrook TL, Kreder HJ, Mayou R, Nast-Kolb D, Pirente N, Schelling G, Tiling T, Yates D; MI Consensus Group. Quality of life in patients with multiple injuries--basic issues, assessment, and recommendations. Restor Neurol Neurosci. 2002;20(3-4):125-34.
- Raat H, Landgraf JM, Oostenbrink R, Moll HA, Essink-Bot ML. Reliability and validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) in a general population and respiratory disease sample. Qual Life Res. 2007 Apr;16(3):445-60. doi: 10.1007/s11136-006-9134-8. Epub 2006 Nov 17.
- Draaijers LJ, Tempelman FR, Botman YA, Kreis RW, Middelkoop E, van Zuijlen PP. Colour evaluation in scars: tristimulus colorimeter, narrow-band simple reflectance meter or subjective evaluation? Burns. 2004 Mar;30(2):103-7. doi: 10.1016/j.burns.2003.09.029.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Burns
-
American Scitech InternationalJohnson & JohnsonUnknownBurns | Electric BurnsUnited States
-
MediWound LtdUnknownBurns, Upper Extremity | Burns, Lower ExtremitySlovakia
-
Singapore General HospitalUnknownAcute Thermal BurnsSingapore
-
RenovaCare, IncActive, not recruitingBurns | Burns Second Degree | Burns Deep Second DegreeUnited States
-
MediWound LtdCompletedThermal BurnsUnited States, Israel, Belgium, Czechia, Georgia, Germany, Italy, Romania
-
Sun Yat-sen UniversityCompleted
-
MediWound LtdActive, not recruitingThermal BurnsUnited States, United Kingdom, Spain, Georgia, Belgium, Poland, Germany, Hungary, India, Italy, Netherlands, Romania, Slovakia, Ukraine
-
Virginia Commonwealth UniversityNot yet recruiting
-
The Hong Kong Polytechnic UniversityCompleted
-
St. Justine's HospitalRecruiting
Clinical Trials on laser Doppler imager (Moor)
-
Chelsea and Westminster NHS Foundation TrustRoyal College of Surgeons of EnglandUnknownThermography | Laser Doppler Blood Flow | Spectrophotometric Intracutaneous AnalysisUnited Kingdom
-
Birmingham Women's and Children's NHS Foundation...RecruitingEndometrium | VascularizationUnited Kingdom
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...Unknown
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...UnknownChronic Obstructive Pulmonary DiseaseChina
-
University of MalagaHealth Service of AndaluciaUnknown
-
Université Libre de BruxellesTerminatedIschemic Heart Disease | Coronary Microvascular Disease | Microvascular DiseaseBelgium
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...UnknownChronic Stable Angina PectorisChina
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical UniversityUnknownChronic Obstructive Pulmonary DiseaseChina
-
University of LeedsUnknown
-
Oslo University HospitalCompletedBreast Reconstruction | Skin PerfusionNorway