Handheld Infrared Thermometer to Evaluate Cellulitis

NCT03846635 | Completed

• 1 other identifier: 2019-4850
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulitis; Cellulitis of Arm; Cellulitis of Leg

Keywords

Cellulitis; Temperature; Venous Stasis; Lymphedema

Outcome Measures

Primary Outcomes (1)

• Difference in skin temperature between affected and contra-lateral limb

  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.

  Skin temperature measurement at time of enrolment

Secondary Outcomes (3)

• Change in Skin Temperature

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

• Change in Maximal Dimensions of Cellulitis

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

• Clinical symptoms of cellulitis as measured by the patient global impression of change scale

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Cellulitis; Varicose Ulcer; Lymphedema

Condition Hierarchy (Ancestors)

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

Study Officials

• Todd C Lee, MD MPH FACP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 19, 2019
• Study Start: August 28, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)