Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis

NCT01706913 | Completed

• 1 other identifier: DermFound-2008A058574
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Length of hospital stay

  Will be measured at day of patient discharge

Other Outcomes (1)

• Readmission rate

  2 weeks after patient discharge

Study Arms (2)

No consult

NO INTERVENTION

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

Dermatology Consult

ACTIVE COMPARATOR

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.

Other: Dermatology consult

Interventions

Dermatology consult OTHER

Dermatology Consult

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 medicine team

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.

Sponsors & Collaborators

• Dermatology Foundation: collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 29453872 DERIVED

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniela Kroshinsky, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2018
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)