A Study Assessing the Impact of Dermatology Consultation in Patients Presenting With Possible Cellulitis

Completed · Not applicable

Conditions studied: Cellulitis

In brief

This is a randomized, controlled study to compare patients evaluated by primary care physicians alone versus patients who are additionally evaluated by a dermatologist at the primary care physician"s office, aiming to demonstrate that visits to the primary care physician"s (PCP) office that involve both the PCP and an on-site dermatology consultation will reduce hospital admission rates. The hypothesis of this study is that obtaining outpatient dermatology consultations during a patient"s initial presentation to a primary care office will reduce admissions for cellulitis with accuracy. The primary objective will be to measure the difference in the proportion of patients requiring hospital admission utilizing a dermatology consultation at the PCP"s office (active arm) versus primary care evaluation alone (control arm) by calculating risk ratios and risk differences. The risk of admission for each arm will be assessed once the study has been completed. The secondary endpoint will be admission versus discharge home at a dermatology follow-up visit to assess accuracy of initial assessment. An additional endpoint will be to determine if any differences in frequencies of cellulitis and admission exist based on age and immunosuppression. Exploratory analyses will assess the percentage of patients with a concomitant known predisposing factor for recurrent cellulitis such as lymphedema, leg ulceration, tinea pedis, or onychomycosis, as well as the association of fever \>100.5 F and a history of a prior episode of cellulitis.

Key facts

Study ID

NCT01795092

Run by

Massachusetts General Hospital

People needed

29

Starts

2012-02-01

Expected to finish

2012-12-01

Last updated by the study team

2013-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand and sign informed consent.
• Able to complete study and comply with study procedures.
• Presumed clinical diagnosis of cellulitis by primary care physician

You may not qualify if…

• Have a known postoperative site infection or abscess
• Have a human/animal bite
• Have known osteomyelitis
• Have a hardware/line infection
• Are under the age of 18
• Have a history of transplantation less than six months after initial transplant and/or if they have had an episode of acute rejection in the last 90 days
• Known use of antithymocyte globulin or campath in the last 6 months or more than 20 mg/day of prednisone for more than 30 days
• Are a known prisoner.
• Are decisionally-impaired.
• Have abnormal vital signs defined as systolic blood pressure <90 mmHg, diastolic blood pressure <80 mmHg, heart rate greater than 90 beats per minute or less than 50 beats per minute, respiratory rate greater than 20, or temperature > 100.5 F.
• Are known to be pregnant.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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