Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 416
- Locations
- 1
- Primary Endpoint
- Skin Temperature Difference Between Affected and Unaffected Legs for Participants with Cellulitis
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant is presenting to the University of Wisconsin Emergency Department
- •Participant has an acute skin complaint on the lower extremity
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Skin Temperature Difference Between Affected and Unaffected Legs for Participants with Cellulitis
Time Frame: 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
Time Frame: up to one hour
Determine differences in skin surface temperatures between cases of pseudocellulitis and cellulitis (on the affected legs).
Secondary Outcomes
- Change in Diagnostic Confidence as Measured by Physician Self-Report(up to one hour)
- Diagnostic agreement with expert review panel(6 months)