search
Back to results

Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis

Primary Purpose

Cellulitis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dermatology consult
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cellulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No consult

Dermatology Consult

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Antibiotic usage
We will be measuring the difference between antibiotic usage in patients in the control group as compared with the treatment group

Secondary Outcome Measures

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.

Full Information

First Posted
September 25, 2012
Last Updated
April 4, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Dermatology Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01706913
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dermatology Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No consult
Arm Type
No Intervention
Arm Description
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
Arm Title
Dermatology Consult
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Dermatology consult
Primary Outcome Measure Information:
Title
Antibiotic usage
Description
We will be measuring the difference between antibiotic usage in patients in the control group as compared with the treatment group
Time Frame
2 weeks after discharge from hospital stay
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
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.
Time Frame
Will be measured at day of patient discharge
Other Pre-specified Outcome Measures:
Title
Readmission rate
Description
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.
Time Frame
2 weeks after patient discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Kroshinsky, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29453872
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.
Results Reference
derived

Learn more about this trial

Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis

We'll reach out to this number within 24 hrs