Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis

Cellulitis Clinical Trial

Official title:

A Randomized Controlled Study to Assess the Impact of Dermatology Consultations on the Hospital Course of Patients Admitted for Cellulitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01706913
• Other study ID #: DermFound-2008A058574
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 246
• Est. completion date: December 31, 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cellulitis

Intervention

Other:
• Dermatology consult

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dermatology Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Readmission rate	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.	2 weeks after patient discharge
Primary	Antibiotic usage	We will be measuring the difference between antibiotic usage in patients in the control group as compared with the treatment group	2 weeks after discharge from hospital stay
Secondary	Length of hospital stay	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.	Will be measured at day of patient discharge