Dermatology Consultation for Cellulitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Antithymocyte globulin, Campath, Prednisone

Disqualifiers: Postoperative infection, Osteomyelitis, Transplantation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Hospital stay duration

246 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Dermatology Consultation for Cellulitis?

Research shows that dermatology consultations improve the accuracy of diagnosing cellulitis, which can lead to better management and outcomes for patients. Specifically, using teledermatology with additional tools like questionnaires and thermal images can significantly increase diagnostic accuracy. ^{1 2 3 4 5}

Is dermatology consultation for cellulitis generally safe?

Dermatological procedures are generally considered safe, but there is a potential for serious adverse events. Most dermatologists perform these procedures in outpatient settings and take steps to minimize risks, such as screening for risk factors before surgery. ^{6 7 8 9 10}

How is dermatology consultation different from other treatments for cellulitis?

Dermatology consultation for cellulitis is unique because it focuses on improving diagnostic accuracy, which can prevent misdiagnosis and inappropriate treatment. Unlike standard treatments that directly target the infection, this approach uses expert evaluation, potentially including teledermatology and thermal imaging, to ensure the correct condition is being treated. ^{1 2 3 11 12}

What is the purpose of this trial?

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.

Research Team

Daniela Kroshinsky, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults who can consent and follow study procedures, with a presumed diagnosis of cellulitis by the medical team. It excludes those under 18, pregnant women, prisoners, patients with certain infections or recent transplants, on high-dose steroids, or with abnormal vital signs.

Inclusion Criteria

Able to understand and sign informed consent

Able to complete study and comply with study procedures

My doctor thinks I have cellulitis.

Exclusion Criteria

You have an infection around any medical devices or tubes in your body.

I had a transplant less than 6 months ago or faced rejection in the last 3 months.

I have been diagnosed with osteomyelitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Patients are admitted to the hospital for cellulitis and receive either standard care or additional dermatology consultation within 24 hours

Hospital stay duration

Follow-up

Participants are monitored for readmission rates and antibiotic usage after discharge

4 weeks

1 follow-up visit in dermatology clinic for treatment group, 1 follow-up phone call for control group

Treatment Details

Interventions

• Dermatology Consultation

Trial Overview The study compares standard care by internal medicine hospitalists to care that includes an early dermatology consult within 24 hours of admission for cellulitis. The goal is to see if this reduces hospital stay length, readmission rates, costs and antibiotic use.

Participant Groups

Group I: Dermatology Consult Active Control 1 Intervention

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.

Group II: No consult Active Control 1 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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dermatology Foundation

Collaborator

Trials

5

Recruited

360+

Findings from Research

Current strategies for monitoring adverse events (AEs) in dermatologic surgery are inconsistent, with morbidity and mortality conferences being the most common reporting method, but more sensitive approaches like retrospective medical record reviews and anonymous electronic systems exist.

There is no standard for AE reporting in dermatologic surgery, highlighting the need for pilot studies to establish effective measures that can enhance AE detection and improve patient safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detecting adverse events in dermatologic surgery. Pinney, D., Pearce, DJ., Feldman, SR.[2019]

A retrospective study of New Zealand dermatologists revealed that while dermatological surgeries in outpatient settings are generally safe, with low rates of infection (<3.5%) and bleeding (<2%), there is a need for improved preoperative and intraoperative monitoring practices.

Most dermatologists do not routinely record vital signs during procedures and often do not withhold anticoagulation or antiplatelet therapies, indicating a potential gap in safety protocols that could be addressed to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative management and the associated rate of adverse events in dermatological procedures performed by dermatologists in New Zealand. Chan, BC., Patel, DC.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acute inflammatory edema: A mimicker of cellulitis in critically ill patients. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The ALT-70 predictive model outperforms thermal imaging for the diagnosis of lower extremity cellulitis: A prospective evaluation. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

The utility of augmented teledermatology to improve dermatologist diagnosis of cellulitis: a cross-sectional study. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Prospective evaluation of the management of moderate to severe cellulitis with parenteral antibiotics at a paediatric day treatment centre. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Treatment failure in emergency department patients with cellulitis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Detecting adverse events in dermatologic surgery. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Grading dermatologic adverse events of cancer treatments: the Common Terminology Criteria for Adverse Events Version 4.0. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Cutaneous adverse reactions following the administration of nonsteroidal antiinflammatory drugs and antibiotics: an Italian survey. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

Skin Reactions to Immune Checkpoint Inhibitors. [2023]

10. Australia pubmed.ncbi.nlm.nih.gov

Perioperative management and the associated rate of adverse events in dermatological procedures performed by dermatologists in New Zealand. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Risk Factors Predicting Cellulitis Diagnosis in a Prospective Cohort Undergoing Dermatology Consultation in the Emergency Department. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Inpatient Consultative Dermatology. [2015]