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Handheld Infrared Thermometer to Evaluate Cellulitis (HI-TEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03846635
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date February 8, 2019
First Posted Date February 19, 2019
Last Update Posted Date September 23, 2020
Actual Study Start Date August 28, 2018
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 17, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 17, 2019)
  • 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."
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Handheld Infrared Thermometer to Evaluate Cellulitis
Official Title Handheld Infrared Thermometer to Evaluate Cellulitis
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cellulitis
  • Cellulitis of Arm
  • Cellulitis of Leg
Intervention Not Provided
Study Groups/Cohorts 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 10, 2020)
52
Original Estimated Enrollment
 (submitted: February 17, 2019)
50
Actual Study Completion Date January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03846635
Other Study ID Numbers 2019-4850
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators Not Provided
Investigators
Principal Investigator: Todd C Lee, MD MPH FACP McGill University Health Centre/Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date September 2020