NCT03846635: HI-TEC

Handheld Infrared Thermometer to Evaluate Cellulitis

Completed Last updated 23 September 2020

What this trial tests

trial in Cellulitis in 52 participants. Completed in 31 January 2020.

Timeline

28 August 2018

Primary endpoint
31 January 2020

31 January 2020

Quick facts

Lead sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre
Status	Completed
Study type	OBSERVATIONAL
Enrollment	52
Start date	28 August 2018
Primary completion	31 January 2020
Estimated completion	31 January 2020
Sites	1 location across Canada

Conditions studied

• Cellulitis — all drugs for Cellulitis →
• Cellulitis of Arm — all drugs for Cellulitis of Arm →
• Cellulitis of Leg — all drugs for Cellulitis of Leg →

Sponsor

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

Who can join

18 and older, any sex, with Cellulitis or Cellulitis of Arm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.