NCT04928235

Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 416 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cellulitis
• Skin and Subcutaneous Tissue Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Thermal Imaging as Diagnostic Adjunct	Thermal images of the participants lower extremities will be taken and skin surface temperature values will be provided to the healthcare provider for review during the emergency department encounter.

Timeline

• Start date: 2021-07-18
• Primary completion: 2023-01-18
• Completion: 2023-02-18
• First posted: 2021-06-16
• Last updated: 2023-12-07

Locations

1 site across 1 country: United States