Clinical trial NCT01706913: Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis
Official title: A Randomized Controlled Study to Assess the Impact of Dermatology Consultations on the Hospital Course of Patients Admitted for Cellulitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cellulitis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dermatology Foundation
First posted: 2012-10-15
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized, controlled study to compare patients evaluated and managed by internal medicine hospitalists alone versus patients who are additionally evaluated by a dermatologist when they are admitted to the hospital, aiming to demonstrate that hospital admissions for cellulitis that involve early dermatology consultation will reduce hospital length of stay, readmission rates, prevalence of pseudocellulitis, cost, and antibiotic usage. The hypothesis of this study is that obtaining inpatient dermatology consultations, within 24 hours of a patient being admitted to the hospital for cellulitis, will reduce the length of stay, readmission rate, cost, and antibiotic usage of the patient"s admission as well as properly evaluate and diagnose patients with pseudocellulitis. The primary objective will be to measure the difference in the length of stay for patients who are randomized to a dermatology consultation within 24 hours of hospital admission (active arm) versus being managed by an internal medicine hospitalist alone, as is the standard of care (control arm). The length of stay for each arm will be assessed once the study has been completed. The secondary endpoint will be to measure readmission rates for cellulitis after patients are discharged from the hospital. An additional endpoint will be to determine if antibiotic usage differs between patients randomized to a dermatology consultation and those not. 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.


Eligibility criteria: Inclusion Criteria:

* Able to understand and sign informed consent
* Able to complete study and comply with study procedures
* Presumed clinical diagnosis of cellulitis by medicine team

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Antibiotic usage
timeFrame: 2 weeks after discharge from hospital stay
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Will be measured at day of patient discharge
Other outcomes:
measure: Readmission rate
timeFrame: 2 weeks after patient discharge
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniela Kroshinsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ko LN, Garza-Mayers AC, St John J, Strazzula L, Vedak P, Shah R, Dobry AS, Rao SR, Milne LW, Parry BA, Kroshinsky D. Effect of Dermatology Consultation on Outcomes for Patients With Presumed Cellulitis: A Randomized Clinical Trial. JAMA Dermatol. 2018 May 1;154(5):529-536. doi: 10.1001/jamadermatol.2017.6196.