Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis
| Tracking Information | |||||
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| First Received Date ICMJE | September 25, 2012 | ||||
| Last Updated Date | October 12, 2012 | ||||
| Start Date ICMJE | October 2012 | ||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01706913 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE |
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. |
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| Original Other Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis | ||||
| Official Title ICMJE | A Randomized Controlled Study to Assess the Impact of Dermatology Consultations on the Hospital Course of Patients Admitted for Cellulitis | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Cellulitis | ||||
| Intervention ICMJE | Other: Dermatology consult | ||||
| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 248 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01706913 | ||||
| Other Study ID Numbers ICMJE | DermFound-2008A058574 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Daniela Kroshinsky, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Dermatology Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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