Cost-effectiveness of Laser Doppler Imaging in Burn Care

Not Applicable

Completed

• Conditions: Burns
• Interventions: Device: laser Doppler imager (Moor)

• Registration Number: NCT01489540
• Lead Sponsor: Association of Dutch Burn Centres

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-30
• Status Verified: 2011-12
• Study Start: 2011-12
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-09
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
new diagnostic strategy	laser Doppler imager (Moor)	Combination of laser Doppler imaging and clinical assessment of burn depth

Primary Outcome Measures

Name	Time	Method
Wound healing time	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)

Secondary Outcome Measures

Name	Time	Method
The effect of LDI on patient outcomes: quality of life and scar quality	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)
The effect of LDI on diagnostic and therapeutic decisions	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
The effect of LDI on total (medical and non medical) costs	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
The cost-effectiveness of LDI compared to the standard diagnostic strategy	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).

Trial Locations

Locations (3)

Red Cross Hospital; 🇳🇱 Beverwijk, Noord-Holland, Netherlands

Maasstad Hospital; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Martini Hospital; 🇳🇱 Groningen, Netherlands