Cost-effectiveness of Laser Doppler Imaging in Burn Care

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489540
• Other study ID #: 2011-47
• Status: Completed
• Phase: N/A
• First received: November 30, 2011
• Last updated: September 18, 2013
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2011
• Source: Association of Dutch Burn Centres
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• laser Doppler imager (Moor)
The laser Doppler imager measures the blood flow of the skin/burn

Locations

Country	Name	City	State
Netherlands	Red Cross Hospital	Beverwijk	Noord-Holland
Netherlands	Martini Hospital	Groningen
Netherlands	Maasstad Hospital	Rotterdam	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Association of Dutch Burn Centres	Dutch Burns Foundation, Stichting Nuts Ohra

Country where clinical trial is conducted

Netherlands, 

References & Publications (12)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. Review. — View 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. — View Citation

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. Epub 2006 Nov 17. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing time	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	No
Secondary	The effect of LDI on patient outcomes: quality of life and scar quality	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): Baseline measurement within one month post burn; Second measurement within 3 months post burn; Scar quality is measured after 3 months: Scar elasticity with the Cutometer® Skin Elasticity Meter 575 (Draaijers et al., 2004); Vascularity and pigmentation with the Dermaspectometer (Draaijers et al., 2004); Self-reported scar quality: Patients Observer Scar Assessment Scale (van der Wal et al., 2011)	3 months post burn	No
Secondary	The effect of LDI on diagnostic and therapeutic decisions	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	No
Secondary	The effect of LDI on total (medical and non medical) costs	Costs from a societal perspective are calculated (following the Dutch guidelines from Oostenbrink et al., 2004): Costs during hospital stay; Outpatient costs; Non-hospital and non-medical costs	From injury until 3 months post burn	No
Secondary	The cost-effectiveness of LDI compared to the standard diagnostic strategy	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	No