Handheld Infrared Thermometer to Evaluate Cellulitis

NCT ID: NCT03846635

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2020-01-31

Brief Summary

It can be difficult to differentiate cellulitis from non-infectious mimics, like venous stasis. One way of determining the difference is feeling skin surface temperature. However, this is a subjective measure that is inherently unreliable. It might be possible to objectify this measurement by using a non-contact infrared thermometer at the bedside.

The goal of this study is therefore to assess whether objective difference in skin surface temperature in an area of suspected cellulitis, relative to non-affected skin, has diagnostic utility. It will use the diagnosis of cellulitis by an infectious diseases physician as the gold standard and compare blinded temperature difference between affected and unaffected limbs to that standard. It is hypothesized that measurement of skin surface temperature by non-contact infrared thermometer will help differentiate cellulitis from many non-infectious conditions that mimic cellulitis.

For patients who are hospitalized, the study also plans to see whether a change in this temperature difference is predictive of response to treatment when compared to the FDA standard for early response and patient reported symptoms.

This is a pragmatic, prospective cohort study. Patients with suspected cellulitis who receive an infectious diseases consult (in the emergency room or urgent clinic) will be approached for consent and enrollment. The goal is to enroll approximately 50 patients with a minimum of 10-15 cases of non-cellulitis.

These measurements will not be made available to the treating teams. This is an observational study only comparing the potential value of these measurements to usual clinical care.

Conditions

Cellulitis; Cellulitis of Arm; Cellulitis of Leg

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Suspected Cellulitis

Patients who undergo an infectious diseases consultation for suspected cellulitis of the upper or lower limbs are eligible to be enrolled. Patients who consent to participation will have chart data extracted and undergo a skin surface temperature measurement of the affected area and surrounding skin using a commercially available infrared thermometer. The dimensions of suspected cellulitis are also measured.

Patients with cellulitis admitted to hospital undergo daily measurements of temperature and dimensions. These patients are also asked standardized questions about their symptoms based on the patient global impression of improvement scale.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older;
• English or French-speaking;
• Received an infectious diseases consultation to evaluate proven or suspected cellulitis of the upper or lower extremity, either unilaterally or bilaterally;
• Either no empiric antimicrobials received or, at most, antimicrobials begun within 24 hours of notification for enrollment.

Exclusion Criteria

• Presumptive diagnosis of a soft tissue infection of the trunk, head or neck that does not also involve a limb;
• Patients with only one limb;
• Patients with significant neuropathies or autonomic syndromes that might affect thermoregulation, such as severe diabetic neuropathy or diabetic dysautonomia, neurologic neoplasms and known vitamin deficiencies;
• Soft tissue infections requiring definitive surgical source control, such as abscesses or necrotizing fasciitis.

• Septic arthritis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Todd Lee

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Todd C Lee, MD MPH FACP

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2019-4850

Identifier Type: -

Identifier Source: org_study_id