Handheld Infrared Thermometer to Evaluate Cellulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Difference in skin temperature between affected and contra-lateral limb
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Difference in skin temperature between affected and contra-lateral limb
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
研究者
Todd Lee
Associate Professor of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre