Handheld Infrared Thermometer to Evaluate Cellulitis

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.

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Key information

Conditions

Cellulitis Cardiovascular Diseases Cellulitis of Arm Cellulitis of Leg Connective Tissue Diseases Hemic and Lymphatic Diseases Infections Inflammation Leg Ulcer Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Ulcer Skin and Connective Tissue Diseases Suppuration Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Difference in skin temperature between affected and contra-lateral limb

Time frame: Skin temperature measurement at time of enrolment

The difference in skin surface temperature measured at the site of suspected cellulitis versus the same location on the contra-lateral limb will be compared to the treating physician's diagnosis of cellulitis/not cellulitis.

Secondary outcomes

Change in Skin Temperature

Time frame: Serial measurements daily until (a) discharge or (b) cure of cellulitis whichever comes first up to a maximum of 14 days

For patients who are hospitalized for antibiotic therapy, skin surface temperature of the affected area will be measured on a daily basis.
Change in Maximal Dimensions of Cellulitis

Time frame: Serial measurements daily until (a) discharge or (b) cure of cellulitis whichever comes first up to a maximum of 14 days

For patients who are hospitalized for antibiotic therapy, cellulitis length and width dimensions (FDA early response criteria for cellulitis) will be measured on a daily basis.
Clinical symptoms of cellulitis as measured by the patient global impression of change scale

Time frame: Serial evaluations daily until (a) discharge or (b) cure of cellulitis whichever comes first up to a maximum of 14 days

Patient global impression of change scale (PGIC) as compared to their initial presentation. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: HI-TEC

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Feb 19, 2019
Registry last updated: Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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