Clinical trial NCT04928235: Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department
Official title: Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cellulitis
Skin and Subcutaneous Tissue Infection
Keywords: Diagnostic confidence
Diagnostic accuracy
Diagnostic error
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-06-16
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seeking to include all patients who present to the Emergency Department for a skin related, acute lower extremity complaint and able to provide informed consent.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin Temperature Difference Between Affected and Unaffected Legs for Participants with Cellulitis
timeFrame: up to one hour
measure: Skin Temperature Difference Between Participants Diagnosed with Pseudocellulitis and Cellulitis
timeFrame: up to one hour
Secondary outcomes:
measure: Change in Diagnostic Confidence as Measured by Physician Self-Report
timeFrame: up to one hour
measure: Diagnostic agreement with expert review panel
timeFrame: 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Emergency Department
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Pulia, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: