Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Dermatology Foundation
Information provided by (Responsible Party):
Daniela Kroshinsky, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01706913
First received: September 25, 2012
Last updated: February 19, 2014
Last verified: February 2014

September 25, 2012
February 19, 2014
October 2012
July 2014   (final data collection date for primary outcome measure)
Antibiotic usage [ Time Frame: 2 weeks after discharge from hospital stay ] [ Designated as safety issue: No ]
We will be measuring the difference between antibiotic usage in patients in the control group as compared with the treatment group
Same as current
Complete list of historical versions of study NCT01706913 on ClinicalTrials.gov Archive Site
Length of hospital stay [ Time Frame: Will be measured at day of patient discharge ] [ Designated as safety issue: No ]
We will be comparing the length of admission between the control group and the treatment group to assess whether a dermatology consult has any impact on the length of a patient's hospital stay.
Same as current
Readmission rate [ Time Frame: 2 weeks after patient discharge ] [ Designated as safety issue: No ]
We will be measuring the readmission rate among patients in both groups in order to discover whether a dermatology consult has an impact on readmission rates among patients with cellultis.
Same as current
 
Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis
A Randomized Controlled Study to Assess the Impact of Dermatology Consultations on the Hospital Course of Patients Admitted for Cellulitis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Cellulitis
Other: Dermatology consult
  • No Intervention: No consult
    Those who are in the control group will follow internal medicine hospitalist recommendations alone which will include when and what type of post-discharge follow-up appointments the patient will have. We would like to emphasize that as part of the standard of care, patients in the control arm may still receive a dermatology consult if it is deemed necessary and/or requested. We will not prevent patients or the patient's team of caregivers from requesting a dermatology consultation during the course of hospitalization. A follow-up phone call will be performed two weeks after discharge for patients in the control group in order to confirm the patient's outcome. There will also be a medical record review one month after the patient's initial discharge from the hospital to assess for readmission
  • Active Comparator: Dermatology Consult
    The patients randomized to the treatment group will obtain a dermatology evaluation within 24 hours of being admitted to MGH for their cellulitis. The skin and lymph node exam performed by the dermatologist on patients in the treatment group will be documented in the LMR for the subjects' medical records. Patients who are readmitted for cellulitis within one month of being discharged from the hospital will be considered treatment failures. Patients in the treatment group will have a follow-up visit in dermatology clinic within two weeks after being discharged. There will also be a medical record review performed one month after the patient's initial discharge from the hospital to assess for readmission.
    Intervention: Other: Dermatology consult
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
248
Not Provided
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Daniela Kroshinsky, MD 617-643-3884 dkroshinsky@partners.org
United States
 
NCT01706913
DermFound-2008A058574
No
Daniela Kroshinsky, Massachusetts General Hospital
Massachusetts General Hospital
Dermatology Foundation
Principal Investigator: Daniela Kroshinsky, MD Massachusetts General Hospital
Massachusetts General Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP