Clinical trial NCT03846635: Handheld Infrared Thermometer to Evaluate Cellulitis
Official title: Handheld Infrared Thermometer to Evaluate Cellulitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cellulitis
Cellulitis of Arm
Cellulitis of Leg
Keywords: Cellulitis
Temperature
Venous Stasis
Lymphedema
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As above, our patient population includes patients aged 18 years and older who can communicate in English or French who receive an infectious diseases consultation for cellulitis of a limb.

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.


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

Primary outcomes:
measure: Difference in skin temperature between affected and contra-lateral limb
timeFrame: Skin temperature measurement at time of enrolment
Secondary outcomes:
measure: Change in Skin Temperature
timeFrame: Serial measurements daily until (a) discharge or (b) cure of cellulitis whichever comes first up to a maximum of 14 days
measure: Change in Maximal Dimensions of Cellulitis
timeFrame: Serial measurements daily until (a) discharge or (b) cure of cellulitis whichever comes first up to a maximum of 14 days
measure: Clinical symptoms of cellulitis as measured by the patient global impression of change scale
timeFrame: Serial evaluations daily until (a) discharge or (b) cure of cellulitis whichever comes first up to a maximum of 14 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Todd C Lee, MD MPH FACP
role: PRINCIPAL_INVESTIGATOR
References: