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Handheld Infrared Thermometer to Evaluate Cellulitis (HI-TEC)

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ClinicalTrials.gov Identifier: NCT03846635
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Todd Lee, McGill University Health Center

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.


Condition or disease
Cellulitis Cellulitis of Arm Cellulitis of Leg

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Handheld Infrared Thermometer to Evaluate Cellulitis
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : August 27, 2019
Estimated Study Completion Date : August 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cellulitis

Group/Cohort
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Koray K Demir, MD 5149341934 ext 53333 koray.demir@mail.mcgill.ca

Locations
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Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Koray K Demir, MD         
Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Leighanne O Parkes, MD         
Sponsors and Collaborators
McGill University Health Center
Investigators
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Principal Investigator: Todd C Lee, MD MPH FACP McGill University Health Center
  Study Documents (Full-Text)

Documents provided by Todd Lee, McGill University Health Center:
Study Protocol  [PDF] October 28, 2018


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Responsible Party: Todd Lee, Associate Professor of Medicine, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03846635     History of Changes
Other Study ID Numbers: 2019-4850
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Todd Lee, McGill University Health Center:
Cellulitis
Temperature
Venous Stasis
Lymphedema

Additional relevant MeSH terms:
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Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes