Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department
- Conditions
- CellulitisSkin and Subcutaneous Tissue Infection
- Interventions
- Diagnostic Test: Thermal Imaging as Diagnostic Adjunct
- Registration Number
- NCT04928235
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
The overall purpose of the study is to determine how providing physicians with a quantitative measure of skin surface temperature influences diagnoses and diagnostic confidence in potential cellulitis cases when added to the standard evaluation.
- Detailed Description
Previous literature estimates the emergency department misdiagnosis rate for cellulitis exceeds 30% due to conditions which can mimic cellulitis (termed pseudocellulitis). These diagnostic errors are associated with an estimated $195 to $515 million dollars in avoidable healthcare spending each year. Objective skin surface temperature measurement, obtained via thermal imaging cameras, has been proposed as a diagnostic adjunct that may reduce diagnostic error in cases of suspected cellulitis. One recent study, identified that the maximum affected skin temperature in cellulitis is significantly higher than in pseudocellulitis, and the temperature gradient between affected and unaffected sites in patients with cellulitis is significantly higher than in patients with pseudocellulitis.
The overall purpose of the study is to determine how providing physicians with a quantifiable measure of skin surface temperature information influences diagnoses and diagnostic confidence in potential cellulitis cases when added to standard physical exam techniques
The Aims of the study are to :
Specific Aim 1: To characterize the temperature difference between affected and unaffected limbs in patients with cellulitis in the emergency department.
Specific Aim 2: To characterize the temperature difference between cases of cellulitis and pseudocellulitis
Specific Aim 3: To determine how quantifying temperature gradients changes diagnostic confidence and accuracy when added to the standard diagnostic evaluation for potential cellulitis.
The investigators will prospectively enroll a maximum of 560 patients with non-traumatic lower extremity dermatologic complaints with visible erythema (potential cellulitis) in the University of Wisconsin Emergency Department. A thermal image and a photograph of the affected and the unaffected limbs will be taken.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
- Participant is presenting to the University of Wisconsin Emergency Department
- Participant has an acute skin complaint on the lower extremity
- Participant is has limited English and Spanish proficiency
- There was an acute traumatic injury of affected area in last 5 days- includes burns
- Affected area has a confirmed fracture
- Participant is pregnant
- Participant is a prisoner
- Current complaint is in an area of past surgical procedure (within past 4 weeks)
- Participant has implant or hardware at site
- Animal or human bite is cause of complaint
- Temperature of the leg has been altered in the last one hour
- Unable to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All Participants Thermal Imaging as Diagnostic Adjunct All participants will have thermal imaging of their lower extremities. The temperature values will be shared with the attending physician. The physician will be asked questions about their diagnostic confidence before and after seeing the temperature values.
- Primary Outcome Measures
Name Time Method Skin Temperature Difference Between Affected and Unaffected Legs for Participants with Cellulitis up to one hour Differences in skin surface temperatures of affected and unaffected areas for those with a final diagnosis of cellulitis.
Skin Temperature Difference Between Participants Diagnosed with Pseudocellulitis and Cellulitis up to one hour Determine differences in skin surface temperatures between cases of pseudocellulitis and cellulitis (on the affected legs).
- Secondary Outcome Measures
Name Time Method Change in Diagnostic Confidence as Measured by Physician Self-Report up to one hour Comparison of the change in diagnostic confidence as measured by the attending physician response pre/post thermal imaging review. This was a question developed by the study team and response options include not at all confident, slightly confident, somewhat confident, very confident, extremely confident. No number values are assigned to response values as of yet.
Diagnostic agreement with expert review panel 6 months Provider cellulitis diagnostic assignment (yes/no) will be compared to an expert panel to determine the rate of concordance.
Trial Locations
- Locations (1)
University of Wisconsin Emergency Department
🇺🇸Madison, Wisconsin, United States