Handheld Infrared Thermometer to Evaluate Cellulitis (HI-TEC)
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|ClinicalTrials.gov Identifier: NCT03846635|
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : August 11, 2020
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.
|Condition or disease|
|Cellulitis Cellulitis of Arm Cellulitis of Leg|
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|Official Title:||Handheld Infrared Thermometer to Evaluate Cellulitis|
|Actual Study Start Date :||August 28, 2018|
|Actual Primary Completion Date :||January 31, 2020|
|Actual Study Completion Date :||January 31, 2020|
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.
- 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.
- 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."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846635
|McGill University Health Centre|
|Montreal, Quebec, Canada, H4A 3J1|
|Principal Investigator:||Todd C Lee, MD MPH FACP||McGill University Health Centre/Research Institute of the McGill University Health Centre|